510(k) · Cleared
Recalled · Class II · 2025NIO+ Adult
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Waismed, Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on Jul 22, 2021 as substantially equivalent to K142086 (Waismed, Ltd., 2014) after a 28-day review. Its family tree reaches back 5 generations to 1998. It has been recalled once.
- Decided
- Jul 22, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K981853 (1998). No later device cites it as a predicate yet.
- Root · 5 generations backK981853 Bone Injection Gun (B.I.G.) DeviceWaismed, Ltd. · 1998
- 4 generations backK032885 Vidaport Intraosseous Infusion SystemVidacare Corporation · 2004
- 3 generations backK052408 EZ-IOVidacare Corporation · 2005 · Recalled
- 2 generations backK062940 Bone Injection Gun (B.I.G.)Waismed, Ltd. · 2006
- 1 generation backK142086 Nio -Intraosseous DeviceWaismed, Ltd. · 2014 · Recalled
- This deviceK211968 NIO+ AdultWaismed, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981853 | Bone Injection Gun (B.I.G.) Device | Waismed, Ltd. | 1998 | — |
| −4 | K032885 | Vidaport Intraosseous Infusion System | Vidacare Corporation | 2004 | — |
| −3 | K052408 | EZ-IO | Vidacare Corporation | 2005 | 1 |
| −2 | K062940 | Bone Injection Gun (B.I.G.) | Waismed, Ltd. | 2006 | — |
| −1 | K142086 | Nio -Intraosseous Device | Waismed, Ltd. | 2014 | 1 |
| 0 (this device) | K211968 | NIO+ Adult | Waismed, Ltd. | 2021 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FMI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K142086 | Nio -Intraosseous DeviceSummary page 4…Regulation Name: Hypodermic Single Lumen Needle Product Code: FMI 4. Predicate Device NIO Adult (WaisMed Ltd., K142086). 5. Device Description The NIO+ Adult (NIO+) is intended to be used with the same patient population and… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 5, 2025 | Class II | Z-2119-2025 | Process change control | Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K142086.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
The NIO+ Adult is intended to provide intraosseous (I10) access in the proximal tibia and the humeral head as an alternative to emergency IV access. Per urgent medical necessity, humeral head IO access may be used when rapid fluid or pharmacological resuscitation is required. The device is intended for use in adult patients only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211968 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211968: NIO+ Adult.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211968
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026