510(k) · Cleared

Cleared

F.a.S.T. 1 Intraosseous Infusion System

K970380510(k) TraditionalCleared Apr 25, 199781-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

Pyng Medical Corp. · FMI Needle, Hypodermic, Single Lumen

Cleared on Apr 25, 1997 as substantially equivalent to K913258 (Cook, Inc., 1992) and 2 other predicates after an 81-day review. Its family tree reaches back 1 generation to 1988. 7 later devices descend from it.

Decided: Apr 25, 1997
Review: 81 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K883014 (1988). 3 ancestors in all. 7 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK883014 Modified Intended Use of Monoject Bone Marrow NeedSherwood Medical Co. · 1988
This deviceK970380 F.a.S.T. 1 Intraosseous Infusion SystemPyng Medical Corp. · 1997
Descendant · cites it directly · 4 of its ownK072487 FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008
Descendant · 2 generations on · 3 of its ownK080865 FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008
Descendant · 3 generations on · 2 of its ownK100124 Fastx Sternal Intraosseous DevicePyng Medical Corp. · 2010 · Recalled
Descendant · 3 generations on · 1 of its ownK130487 Fastresponder Sternal Intraosseous DevicePyng Medical Corp. · 2013
Descendant · cites it directly · 1 of its ownK063567 EZ-Mio SternalVidacare Corporation · 2007

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2007high 2 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 7 · See all

K072487FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008 · cites it directly4descendants
K080865FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008 · 2 generations on3descendants
K100124Fastx Sternal Intraosseous DevicePyng Medical Corp. · 2010 · 3 generations on2descendants
K130487Fastresponder Sternal Intraosseous DevicePyng Medical Corp. · 2013 · 3 generations on1descendant
K063567EZ-Mio SternalVidacare Corporation · 2007 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K883014	Modified Intended Use of Monoject Bone Marrow Need	Sherwood Medical Co.	1988	—
0 (this device)	K970380	F.a.S.T. 1 Intraosseous Infusion System	Pyng Medical Corp.	1997	—
+1	K072487	FAST1 Intraosseous Infusion System	Pyng Medical Corp.	2008	—
+2	K080865	FAST1 Intraosseous Infusion System	Pyng Medical Corp.	2008	—
+3	K100124	Fastx Sternal Intraosseous Device	Pyng Medical Corp.	2010	1
+3	K130487	Fastresponder Sternal Intraosseous Device	Pyng Medical Corp.	2013	—
+1	K063567	EZ-Mio Sternal	Vidacare Corporation	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	2	0
2010	1	0
2012	1	0
2013	1	0
2018	1	0

FIG. 1 — Lineage of K970380, 1988–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K913258	Disposable Introsseous Infusion Needles Summary page 1 …he Cook, inc. SUR-FAST® Intraosseous Infusion Needle Set and Components, and the Cook Disposable Intraosseous infusion Needles. The 510(k) numbers for these products are K913258 and K915409. 2. “'SHERWOOD ILLINOIS needle”. Sherwood Medical Co. Monoject® 16 gage lllinois Sternal / lliac Aspiration Needle,…	Cook, Inc.	1992	—
*	K915409	Intraosseous Access Needle Summary page 1 …. SUR-FAST® Intraosseous Infusion Needle Set and Components, and the Cook Disposable Intraosseous infusion Needles. The 510(k) numbers for these products are K913258 and K915409. 2. “'SHERWOOD ILLINOIS needle”. Sherwood Medical Co. Monoject® 16 gage lllinois Sternal / lliac Aspiration Needle, reorder numb…	Cook, Inc.	1992	—
*	K883014	Modified Intended Use of Monoject Bone Marrow Need Summary page 1 …D ILLINOIS needle”. Sherwood Medical Co. Monoject® 16 gage lllinois Sternal / lliac Aspiration Needle, reorder number 8881- 245164. The 510(k) number for this product is K883014. 97-01-31 Page 11 - 1 PYNG MEDICAL CORP. File: SEC11.doc PYNG MEDICAL CORP. coPY # 12 Description of Device: T…	Sherwood Medical Co.	1988	—

Also cleared against K913258: 5 other devices →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K072487	FAST1 Intraosseous Infusion System	Pyng Medical Corp.	2008	4
K063567	EZ-Mio Sternal	Vidacare Corporation	2007	1
K120661	The T.a.L.O.N. Intraossous Infusion System by Vidacre	Vidacare Corporation	2012	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?

None of the 3 ancestors has a recall.
Of its descendants, K072487 (Pyng Medical Corp., 2008) has gone furthest, with 4 descendants of its own.
5 other devices also cite its predicate K913258.

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 F.A.S.T. 1™ Intraosseous Infusion System is intended for intraosseous infusion as an alternative to intravenous access to facilitate emergency resuscitation through the use of drugs and fluids.

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/K970380 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970380: F.a.S.T. 1 Intraosseous Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970380

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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