510(k) · Cleared

Cleared

Sharps Container Model# SC001

K963830510(k) TraditionalCleared Feb 10, 1997139-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

Image Medical, Inc. · FMI Needle, Hypodermic, Single Lumen

Cleared on Feb 10, 1997 as substantially equivalent to K943575 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1994) after a 139-day review. Its family tree reaches back 1 generation to 1994.

Decided: Feb 10, 1997
Review: 139 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K943575 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK943575 B-D Guardian Nestable Sharps CollectorsBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
This deviceK963830 Sharps Container Model# SC001Image Medical, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K943575	B-D Guardian Nestable Sharps Collectors	Bd Becton Dickinson Vacutainer Systems Preanalytic	1994	—
0 (this device)	K963830	Sharps Container Model# SC001	Image Medical, Inc.	1997	—

FIG. 1 — Lineage of K963830, 1994–1997Source: 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

Get a 510(k) 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K943575	B-D Guardian Nestable Sharps Collectors Summary page 1 …fitting plestic lids end are disposal. Our preduct has & aluminum screw on lid which is tight fiting and prevents lsakage of the contents. 1. B.D. Home Sharps Container K943575 2, Sage Sharps Disposal Systsm NB43860 Tosting: 60681 aluminum has & shear rate of 20000 PS\| with a wall thickness of .007 and…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1994	—
Kept off the family tree	K843860	FDA’s K843860 is Oxyscreen Our OCR of the scanned summary read K843860, FDA’s number for Oxyscreen (Erich Jaeger, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Sage Sharps Disposal System”. Kept off the family tree.	Erich Jaeger, Inc.	1984	—

Also cleared against K943575: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.
4 other devices also cite its predicate K943575.

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?

This container is for use by Law Enforcement Agencies. Law Enforcement Officials who frequently encounter syringes and other sharps during searches of suspects, vehicles, property or location.

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/K963830 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963830: Sharps Container Model# SC001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963830

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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