510(k) K142086 ยท FMI Needle, Hypodermic, Single Lumen
NIO -INTRAOSSEOUS DEVICE
| Applicant | Waismed, Ltd., Washington DC, US |
| Decision | Substantially Equivalent, Aug 28, 2014 |
| Received | Jul 31, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142086
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2025 | Waismed Ltd. Brand Name: NIO-A
Product Name: NIO Intraosseous Device Adult
Model/Catalog Number: 105000603
Software Version: N/A
Product Description: NIO devices are a spring-based, automatic intra-osseous access Open, Classified |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.