510(k) · Cleared
ClearedBone Injection Gun (B.I.G.) for Pediatrics, Model 1ST
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 Oct 11, 2002 as substantially equivalent to K981853 (Waismed, Ltd., 1998) and 2 other predicates after a 79-day review. Its family tree reaches back 1 generation to 1992. 17 later devices descend from it.
- Decided
- Oct 11, 2002
- Review
- 79 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K915409 (1992). 3 ancestors in all. 17 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK915409 Intraosseous Access NeedleCook, Inc. · 1992
- This deviceK022415 Bone Injection Gun (B.I.G.) for Pediatrics, Model 1STWaismed, Ltd. · 2002
- Descendant · cites it directly · 16 of its ownK043490 PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation · 2005
- Descendant · 2 generations on · 13 of its ownK052195 EZ-Mio Manual DriverVidacare Corporation · 2005
- Descendant · 3 generations on · 3 of its ownK080865 FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008
- Descendant · 3 generations on · 3 of its ownK062956 EZ-Mio, EZ-IO Distal TibiaVidacare Corporation · 2006
- Descendant · 2 generations on · 3 of its ownK051992 Powered PD-IO Intraosseous Infusion SystemVidacare Corporation · 2005
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K043490PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation · 2005 · cites it directly16descendants
- K052195EZ-Mio Manual DriverVidacare Corporation · 2005 · 2 generations on13descendants
- K080865FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008 · 3 generations on3descendants
- K062956EZ-Mio, EZ-IO Distal TibiaVidacare Corporation · 2006 · 3 generations on3descendants
- K051992Powered PD-IO Intraosseous Infusion SystemVidacare Corporation · 2005 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915409 | Intraosseous Access Needle | Cook, Inc. | 1992 | — |
| 0 (this device) | K022415 | Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST | Waismed, Ltd. | 2002 | — |
| +1 | K043490 | PD-IO Disposable Intraosseous Infusion Needle | Vidacare Corporation | 2005 | — |
| +2 | K052195 | EZ-Mio Manual Driver | Vidacare Corporation | 2005 | — |
| +3 | K080865 | FAST1 Intraosseous Infusion System | Pyng Medical Corp. | 2008 | — |
| +3 | K062956 | EZ-Mio, EZ-IO Distal Tibia | Vidacare Corporation | 2006 | — |
| +2 | K051992 | Powered PD-IO Intraosseous Infusion System | Vidacare Corporation | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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? (3)
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…N a m e : Needle, Hypodermic, Single Lumen Predicate Devices 0 The Bone Injection Gun Device (Waismed Ltd.), cleared under K981853 0 The Intraosseous Access Needles (Cook Inc.), cleared under K915409, K913258… | 1998 |
| * | K915409 | Intraosseous Access NeedleSummary page 1…e Bone Injection Gun Device (Waismed Ltd.), cleared under K981853 0 The Intraosseous Access Needles (Cook Inc.), cleared under K915409, K913258 8-3 Intended Use: The B.I.GTM-Bone injection Gun for… | 1992 |
| * | K913258 | Disposable Introsseous Infusion NeedlesSummary page 1…jection Gun Device (Waismed Ltd.), cleared under K981853 0 The Intraosseous Access Needles (Cook Inc.), cleared under K915409, K913258 8-3 Intended Use: The B.I.GTM-Bone injection Gun for Pediatri… | 1992 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043490 | PD-IO Disposable Intraosseous Infusion Needle | 2005 | 16 |
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?
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 B.I.Gm- Bone injection Gun for Pediatrics is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients up to 12 years of age,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022415 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022415: Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022415
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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