510(k) · Cleared

Cleared

Doyle Extractor

K955748510(k) TraditionalCleared Mar 14, 199690-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

Safetech Intl., Inc. · FMI Needle, Hypodermic, Single Lumen

Cleared on Mar 14, 1996 as substantially equivalent to K810187 (United States Surgical, A Division of Tyco Healthc, 1981) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1976. 2 later devices descend from it.

Decided: Mar 14, 1996
Review: 90 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K760733 (1976). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK760733 Skin Staple ExtractorETHICON, Inc. · 1976
This deviceK955748 Doyle ExtractorSafetech Intl., Inc. · 1996
Descendant · cites it directly · 1 of its ownK973497 HuberlocMedcare Medical Group, Inc. · 1998
Descendant · 2 generations on · 0 of its ownK021916 Harmac Huber Needle Safety Device, H2984001Harmac Medical Products, Inc. · 2002

Most influential descendants

Showing 2 of 2 · See all

K973497HuberlocMedcare Medical Group, Inc. · 1998 · cites it directly1descendant
K021916Harmac Huber Needle Safety Device, H2984001Harmac Medical Products, Inc. · 2002 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K760733	Skin Staple Extractor	ETHICON, Inc.	1976	—
0 (this device)	K955748	Doyle Extractor	Safetech Intl., Inc.	1996	—
+1	K973497	Huberloc	Medcare Medical Group, Inc.	1998	—
+2	K021916	Harmac Huber Needle Safety Device, H2984001	Harmac Medical Products, Inc.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1991	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2002	1	0

FIG. 1 — Lineage of K955748, 1976–2002Source: 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
*	K810187	Auto Suture PSS Skin Stapling Instrument Summary page 2 …Extractor is similar in design, function, and intended use to accessories for other temporary or removable devices. Examples include the AutoSuture skin staple remover (K810187, K914130)--a disposable staple remover which is similar in design, appearance, and function to the Doyle Extractor, as well as th…	United States Surgical, A Division of Tyco Healthc	1981	—
*	K914130	Auto Suture Titanium Skin and Fascia Staples Summary page 2 …r is similar in design, function, and intended use to accessories for other temporary or removable devices. Examples include the AutoSuture skin staple remover (K810187, K914130)--a disposable staple remover which is similar in design, appearance, and function to the Doyle Extractor, as well as the Ethicon…	United States Surgical, A Division of Tyco Healthc	1991	—
*	K760733	Skin Staple Extractor Summary page 2 …K810187, K914130)--a disposable staple remover which is similar in design, appearance, and function to the Doyle Extractor, as well as the Ethicon skin staple extractor (K760733). Skin siaple removers utilize the principle of a simple lever to apply adequate force for removal of the skin staple; the Doyle…	ETHICON, Inc.	1976	—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K973497	Huberloc	Medcare Medical Group, Inc.	1998	1

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, K973497 (Medcare Medical Group, Inc., 1998) has gone furthest, with 1 descendant 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 Doyle Extractor is a needle extractor intended for use as an accessory to IV administration sets. Specifically, the Doyle Extractor is intended for use during the removal of right-angle needles from implanted IV ports.

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/K955748 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955748: Doyle Extractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955748

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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