510(k) · Cleared
Recalled · Class II · 2025Nio -Intraosseous Device
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 Aug 28, 2014 as substantially equivalent to K981853 (Waismed, Ltd., 1998) and 1 other predicate after a 28-day review. Its family tree reaches back 4 generations to 1998. 3 later devices descend from it. It has been recalled once.
- Decided
- Aug 28, 2014
- Review
- 28 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K981853 (1998). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK981853 Bone Injection Gun (B.I.G.) DeviceWaismed, Ltd. · 1998
- 3 generations backK032885 Vidaport Intraosseous Infusion SystemVidacare Corporation · 2004
- 2 generations backK052408 EZ-IOVidacare Corporation · 2005 · Recalled
- 1 generation backK062940 Bone Injection Gun (B.I.G.)Waismed, Ltd. · 2006
- This deviceK142086 Nio -Intraosseous DeviceWaismed, Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK160805 NIO-PWaismed, Ltd. · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK211968 NIO+ AdultWaismed, Ltd. · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK191258 Intraosseous infusion deviceEinstein Works, LLC · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981853 | Bone Injection Gun (B.I.G.) Device | Waismed, Ltd. | 1998 | — |
| −3 | K032885 | Vidaport Intraosseous Infusion System | Vidacare Corporation | 2004 | — |
| −2 | K052408 | EZ-IO | Vidacare Corporation | 2005 | 1 |
| −1 | K062940 | Bone Injection Gun (B.I.G.) | Waismed, Ltd. | 2006 | — |
| 0 (this device) | K142086 | Nio -Intraosseous Device | Waismed, Ltd. | 2014 | — |
| +1 | K160805 | NIO-P | Waismed, Ltd. | 2016 | 1 |
| +1 | K211968 | NIO+ Adult | Waismed, Ltd. | 2021 | 1 |
| +2 | K191258 | Intraosseous infusion device | Einstein Works, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K981853 | Bone Injection Gun (B.I.G.) DeviceSummary page 4…manufactured by Waismed Ltd.: Device Manufacturer 510(k) No. B.I.G. (Bone Injection Gun) Waismed Ltd. K981853, K062940 Device Description: The NIO Adult device is a modification to the company’s cleared Adult B.I.G - Bone Injection Gun… | 1998 |
| * | K062940 | Bone Injection Gun (B.I.G.)Summary page 4…red by Waismed Ltd.: Device Manufacturer 510(k) No. B.I.G. (Bone Injection Gun) Waismed Ltd. K981853, K062940 Device Description: The NIO Adult device is a modification to the company’s cleared Adult B.I.G - Bone Injection Gun === Page… | 2006 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-2118-2025 | 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 16 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K160805 (Waismed, Ltd., 2016) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K981853.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only.
The NIO Adult is indicated for use in providing intraosseous access as an alternative to IV access during emergencies. Humeral head access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible. The device is for use in adult patients only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142086: Nio -Intraosseous Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142086
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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