510(k) · Cleared
ClearedBone Injection Gun (B.I.G.)
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 Dec 22, 2006 as substantially equivalent to K981853 (Waismed, Ltd., 1998) and 1 other predicate after an 85-day review. Its family tree reaches back 3 generations to 1998. 5 later devices descend from it.
- Decided
- Dec 22, 2006
- Review
- 85 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K981853 (1998). 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK981853 Bone Injection Gun (B.I.G.) DeviceWaismed, Ltd. · 1998
- 2 generations backK032885 Vidaport Intraosseous Infusion SystemVidacare Corporation · 2004
- 1 generation backK052408 EZ-IOVidacare Corporation · 2005 · Recalled
- This deviceK062940 Bone Injection Gun (B.I.G.)Waismed, Ltd. · 2006
- Descendant · cites it directly · 3 of its ownK142086 Nio -Intraosseous DeviceWaismed, Ltd. · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK160805 NIO-PWaismed, Ltd. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK211968 NIO+ AdultWaismed, Ltd. · 2021 · Recalled
- Descendant · 3 generations on · 0 of its ownK191258 Intraosseous infusion deviceEinstein Works, LLC · 2019
- Descendant · cites it directly · 0 of its ownK132583 EZ-IO Intraosseous Infusion SystemVidacare Corporation · 2014
Most influential descendants
Showing 5 of 5 · See all- K142086Nio -Intraosseous DeviceWaismed, Ltd. · 2014 · cites it directly3descendants
- K160805NIO-PWaismed, Ltd. · 2016 · 2 generations on1descendant
- K211968NIO+ AdultWaismed, Ltd. · 2021 · 2 generations on0descendants
- K191258Intraosseous infusion deviceEinstein Works, LLC · 2019 · 3 generations on0descendants
- K132583EZ-IO Intraosseous Infusion SystemVidacare Corporation · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981853 | Bone Injection Gun (B.I.G.) Device | Waismed, Ltd. | 1998 | — |
| −2 | K032885 | Vidaport Intraosseous Infusion System | Vidacare Corporation | 2004 | — |
| −1 | K052408 | EZ-IO | Vidacare Corporation | 2005 | 1 |
| 0 (this device) | K062940 | Bone Injection Gun (B.I.G.) | Waismed, Ltd. | 2006 | — |
| +1 | K142086 | Nio -Intraosseous Device | Waismed, Ltd. | 2014 | 1 |
| +2 | K160805 | NIO-P | Waismed, Ltd. | 2016 | 1 |
| +2 | K211968 | NIO+ Adult | Waismed, Ltd. | 2021 | 1 |
| +3 | K191258 | Intraosseous infusion device | Einstein Works, LLC | 2019 | — |
| +1 | K132583 | EZ-IO Intraosseous Infusion System | Vidacare Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 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 1…ification Name Hypodermic single lumen needle Predicate Devices WaisMed, Ltd., B.I.G. - Bone Injection Gun (K981853) Vidacare Corporation, Humeral Head EZ-IO (K052408)… | 1998 |
| * | K052408 | EZ-IOSummary page 1…edicate Devices WaisMed, Ltd., B.I.G. - Bone Injection Gun (K981853) Vidacare Corporation, Humeral Head EZ-IO (K052408) 17 \\\UDC - 027487/000O01 -2370289v1 Intended Use… | 2005 |
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K142086 (Waismed, Ltd., 2014) has gone furthest, with 3 descendants 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.
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 Bone Injection Gun (BIG) is intended to provide intraosseous access as an alternative to IV access during emergencies. Humeral head IO 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/K062940 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062940: Bone Injection Gun (B.I.G.).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062940
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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