510(k) · Cleared

Cleared

Bone Injection Gun (B.I.G.) Device

K981853510(k) TraditionalCleared Nov 17, 1998175-day reviewClass II21 CFR 880.5570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Waismed, Ltd. · FMI Needle, Hypodermic, Single Lumen

Cleared on Nov 17, 1998 after a 175-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 40 later devices descend from it.

Decided: Nov 17, 1998
Review: 175 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 0

40 later devices descend from it, 5 citing it directly.

This deviceK981853 Bone Injection Gun (B.I.G.) DeviceWaismed, Ltd. · 1998
Descendant · cites it directly · 38 of its ownK032885 Vidaport Intraosseous Infusion SystemVidacare Corporation · 2004
Descendant · cites it directly · 17 of its ownK022415 Bone Injection Gun (B.I.G.) for Pediatrics, Model 1STWaismed, Ltd. · 2002
Descendant · 2 generations on · 16 of its ownK043490 PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation · 2005
Descendant · 2 generations on · 14 of its ownK062833 Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation · 2006
Descendant · 2 generations on · 13 of its ownK052195 EZ-Mio Manual DriverVidacare Corporation · 2005

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2002high 5 (2006) · low 0 (2003)2026

Most influential descendants

Showing 5 of 40 · See all

K032885Vidaport Intraosseous Infusion SystemVidacare Corporation · 2004 · cites it directly38descendants
K022415Bone Injection Gun (B.I.G.) for Pediatrics, Model 1STWaismed, Ltd. · 2002 · cites it directly17descendants
K043490PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation · 2005 · 2 generations on16descendants
K062833Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation · 2006 · 2 generations on14descendants
K052195EZ-Mio Manual DriverVidacare Corporation · 2005 · 2 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K981853	Bone Injection Gun (B.I.G.) Device	Waismed, Ltd.	1998	—
+1	K032885	Vidaport Intraosseous Infusion System	Vidacare Corporation	2004	—
+1	K022415	Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST	Waismed, Ltd.	2002	—
+2	K043490	PD-IO Disposable Intraosseous Infusion Needle	Vidacare Corporation	2005	—
+2	K062833	Powered EZ-IO Bone Marrow Aspiration System	Vidacare Corporation	2006	—
+2	K052195	EZ-Mio Manual Driver	Vidacare Corporation	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	1	0
2005	4	0
2006	5	0
2007	4	0
2008	2	0
2009	1	0
2010	2	0
2011	1	0
2012	2	0
2013	1	0
2014	3	0
2015	2	0
2016	1	0
2017	1	0
2018	1	0
2019	2	0
2021	3	0
2022	1	0
2023	1	0
2025	1	0

FIG. 1 — Lineage of K981853, 1998–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (40)

See all 40

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K032885	Vidaport Intraosseous Infusion System	Vidacare Corporation	2004	38
K022415	Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST	Waismed, Ltd.	2002	17
K062940	Bone Injection Gun (B.I.G.)	Waismed, Ltd.	2006	5
K142086	Nio -Intraosseous Device	Waismed, Ltd.	2014	3
K132583	EZ-IO Intraosseous Infusion System	Vidacare Corporation	2014	0

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?

Of its descendants, K032885 (Vidacare Corporation, 2004) has gone furthest, with 38 descendants of its own.

How does its category compare?

All FMI devices

FMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMI

11in 2025

2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007high 263 (2020) · low 71 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMI

1in 2024

2007high 79 (2010) · low 0 (2016)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMI

2,424in 2025

2007high 4,986 (2023) · low 177 (2008)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 (B.1.G.) 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.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K981853 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981853: Bone Injection Gun (B.I.G.) Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981853

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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