510(k) · Cleared

Cleared

Needle Barn Stick Stopper with Safety Cap, in Kit with Sterile Field Drape

K010038510(k) TraditionalCleared Jan 24, 200119-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

Cambridge Marketing, Inc. · FMI Needle, Hypodermic, Single Lumen

Cleared on Jan 24, 2001 after a 19-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided: Jan 24, 2001
Review: 19 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK010038 Needle Barn Stick Stopper with Safety Cap, in Kit with Sterile Field…Cambridge Marketing, Inc. · 2001
Descendant · cites it directly · 0 of its ownK041158 Atrion Epidural Anesthesia Kit with Atrion Needlevise Sharps…Atrion Medical Products, Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all

K041158Atrion Epidural Anesthesia Kit with Atrion Needlevise Sharps Securing SystemAtrion Medical Products, Inc. · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010038	Needle Barn Stick Stopper with Safety Cap, in Kit with Sterile Field Drape	Cambridge Marketing, Inc.	2001	—
+1	K041158	Atrion Epidural Anesthesia Kit with Atrion Needlevise Sharps Securing System	Atrion Medical Products, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K010038, 2001–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K041158	Atrion Epidural Anesthesia Kit with Atrion Needlevise Sharps Securing System	Atrion Medical Products, Inc.	2004	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, K041158 (Atrion Medical Products, Inc., 2004) has gone furthest, with 0 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)	—

https://510kreport.com/device/K010038 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010038: Needle Barn Stick Stopper with Safety Cap, in Kit with Sterile Field Drape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010038

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026