NIO Infant™ Intraosseous Device
A manual IO access device with a patented Stepped Needle® design for infant proximal-tibia access — from gestational age 36 weeks (min 5 lb) through 3 years.
What is the NIO Infant™? A manual intraosseous (IO) access device (SKU NIO-I) with a patented Stepped Needle® design for proximal-tibia access in patients from gestational age 36 weeks (minimum 5 lb / 2.3 kg) through 3 years. No batteries, assembly, or extra parts — the needle tapers from 14G to 18G as a geometry intended to limit over-penetration in fragile infant bone.
Intraosseous vascular access is an invasive procedure performed only by appropriately trained and credentialed personnel under their scope of practice and local protocol. This page is product information, not a procedural how-to, site-selection guide, or substitute for accredited clinical training.
Key Specifications
| Manufacturer | PerSys Medical / Safeguard Medical |
| SKU | NIO-I |
| Weight (packaged) | 2.5 oz |
| Needle Design | Stepped Needle® — tapers 14G (shaft) to 18G (tip) |
| Penetration Depth | 15 mm (0.6 in); 18G cortex section 2.6 mm |
| Mechanism | Manual (not spring-loaded) |
| Indication | Proximal tibia IO access, gestational age 36 weeks (≥5 lb / 2.3 kg) to 3 years |
| Sterility | Sterile, single-use |
| Shelf Life | 5 years from manufacture |
| Packaging | Peel-back blister pack with fixation dressing |
| FDA Status | FDA-cleared, Class II device |
What It Is
Vascular access in infants is one of the most technically demanding challenges in emergency medicine: peripheral veins are tiny, fragile, and collapse rapidly under physiologic stress, and the time spent attempting peripheral IV access can exceed the intervention window in a critically ill infant. The NIO Infant™ was designed as a reliable, reproducible alternative for trained providers.
Its defining feature is the Stepped Needle® geometry — tapering from 14G at the shaft to 18G at the tip. As the 18G tip crosses the cortex into the medullary cavity, tactile resistance changes, and the transition to the 14G shaft acts as a physical stop intended to prevent over-penetration through the far cortex — a meaningful safety consideration in infant tibias where cortex thickness can be only a few millimeters.
The NIO Infant is a manual device: the provider applies controlled downward pressure to advance the needle, with the Stepped Needle providing both feedback and depth control. It is pocket-sized, lightweight, requires no batteries or assembly, and arrives sterile in a blister pack with a fixation dressing. Landmark identification, insertion, placement confirmation, and fixation are clinical steps performed by the trained provider under local protocol.
See also: NIO Pediatric Intraosseous Device, Go IO Intraosseous Start Kit, and IV/IO & Blood Transfusion Supplies.
When the NIO Infant IO Device Is Needed
- Neonatal cardiac arrest or arrest in infants under 3 years where peripheral IV access is not possible or failed
- Septic shock in neonates and infants — systemic infection causes peripheral vein collapse faster in infants than any other age group
- Pediatric trauma with hemorrhagic shock in infants where the fragility of peripheral veins prevents rapid IV access
- NICU and PICU emergency access when all peripheral and central venous access has failed
- Pre-hospital neonatal emergency (NNT, HEMS) requiring immediate medication or fluid administration
- Status epilepticus in infants under 3 years requiring immediate anticonvulsant delivery
NIO Infant vs. Other Infant IO Access Options
- NIO Infant™ (SKU NIO-I): Manual, Stepped Needle® (14G shaft → 18G tip), 15 mm depth, for GA 36 weeks – 3 years; no batteries; sterile single-use
- B.I.G. Neonatal: Spring-loaded automatic; smaller target market; different insertion mechanism and needle size than NIO Infant
- EZ-IO Pediatric needle (Teleflex): Drill-driven; not recommended for neonates; smallest EZ-IO needle is 15G × 15 mm, not optimized for infant bone cortex thickness
- Manual screw needles (Cook, Jamshidi pediatric): Require rotational force; no depth control geometry; provider skill-dependent
- Umbilical venous access (UVC): Alternative for neonates in clinical settings; not practical for pre-hospital; requires sterile field and specialized technique
- Stepped Needle advantage: 14G-to-18G transition provides tactile feedback and depth limiting unavailable with straight-gauge IO needles
Frequently Asked Questions
Q: What is the Stepped Needle® design and why is it important for infant IO access?
A: The Stepped Needle® tapers from 14 gauge at the outer shaft to 18 gauge at the insertion tip. This design serves two purposes: first, the 14G-to-18G transition provides tactile sensory feedback as the tip penetrates bone cortex and enters the medullary cavity, indicating correct placement. Second, the step acts as a physical depth limiter, preventing the needle from advancing beyond the intended depth into fragile infant bone marrow — critical for preventing far-cortex perforation in the small tibias of neonatal and infant patients.
Q: What is the age and weight range for the NIO Infant?
A: The NIO Infant is indicated for patients from gestational age 36 weeks with a minimum weight of 5 lbs (2.3 kg) through 3 years of age. For patients aged 3–12 years, the NIO Pediatric is the appropriate device. For patients over 12 years and adults, use the NIO Adult (15G) or NIO+ Ruggerized adult device.
Q: Is the NIO Infant manual or automatic?
A: The NIO Infant is a manual device — the provider applies controlled downward pressure to advance the Stepped Needle through the cortex. This differs from the NIO Pediatric and NIO Adult, which are semi-automatic and automatic spring-loaded devices respectively. The manual mechanism for the infant version reflects the reduced force required for infant bone penetration and provides precise tactile feedback.
Q: What drugs and fluids can be administered via the NIO Infant IO route?
A: IO access provides a route for administration of medications (including epinephrine, atropine, adenosine, amiodarone, and anticonvulsants) and for fluid resuscitation with crystalloids, colloids, and blood products. All drugs and fluids that can be administered IV can generally be administered IO. Specific drug dosing, flush volumes, and flow rates via the NIO Infant route are clinical decisions made by the provider per protocol.
Q: Does the NIO Infant come with the Go IO Start Kit?
A: No. The Go IO Start Kit is designed and sized for the NIO Adult and NIO Pediatric. The NIO Infant comes with a fixation dressing. Providers using the NIO Infant should verify compatibility of post-insertion accessories with the infant device's hub geometry before use.
Q: When was the NIO Infant introduced?
A: The NIO Infant was introduced to the U.S. market in late 2019, making it one of the most recent additions to the NIO family. It fills the gap between neonatal and older pediatric patients that neither the NIO Adult nor the original NIO Pediatric was designed to address.
Q: Why is the NIO Infant a manual device?
A: Infant tibias require significantly less insertion force than adult or pediatric tibias. A spring-loaded mechanism calibrated for adult or older pediatric bone would generate excessive force that risks fracturing or over-penetrating fragile neonatal and infant bone. The manual design allows the provider to modulate insertion force in real time based on tactile feedback from the Stepped Needle, making it safer for the smallest patients.
Q: Is the NIO Infant FDA-cleared?
A: Yes. The NIO Infant is an FDA-cleared Class II medical device. As with all IO access devices, its use is indicated for appropriately trained and credentialed medical personnel under their scope of practice and local protocol.
Related searches: NIO infant, infant intraosseous device, stepped needle IO, neonatal IO access, pediatric proximal tibia IO.
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Specifications coming soon. Contact us for detailed product information.
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