510(k) · Cleared

Cleared

Potocky Neddle (TM) Disposable Injection Needle

K910252510(k) TraditionalCleared Mar 4, 199141-day reviewClass II21 CFR 884.5100

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

CooperSurgical, Inc. · HEE Set, Anesthesia, Paracervical

Cleared on Mar 4, 1991 after a 41-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided: Mar 4, 1991
Review: 41 days
Class: Class II
Product code: HEE
Recalls: None
Predicates: 0

3 later devices descend from it, 3 citing it directly.

This deviceK910252 Potocky Neddle (TM) Disposable Injection NeedleCooperSurgical, Inc. · 1991
Descendant · cites it directly · 1 of its ownK021224 Endocervical Block NeedleWallach Surgical Devices, Inc. · 2002
Descendant · cites it directly · 0 of its ownK052365 Cervineedle Disposable Cartridge SyringeRocket Medical Plc · 2005
Descendant · cites it directly · 0 of its ownK980238 Gynex Extended Reach NeedleGynex Corp. · 1998

Most influential descendants

Showing 3 of 3 · See all

K021224Endocervical Block NeedleWallach Surgical Devices, Inc. · 2002 · cites it directly1descendant
K052365Cervineedle Disposable Cartridge SyringeRocket Medical Plc · 2005 · cites it directly0descendants
K980238Gynex Extended Reach NeedleGynex Corp. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K910252	Potocky Neddle (TM) Disposable Injection Needle	CooperSurgical, Inc.	1991	—
+1	K021224	Endocervical Block Needle	Wallach Surgical Devices, Inc.	2002	—
+1	K052365	Cervineedle Disposable Cartridge Syringe	Rocket Medical Plc	2005	—
+1	K980238	Gynex Extended Reach Needle	Gynex Corp.	1998	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2002	1	0
2005	1	0

FIG. 1 — Lineage of K910252, 1991–2005Source: 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 HEE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K021224	Endocervical Block Needle	Wallach Surgical Devices, Inc.	2002	1
K052365	Cervineedle Disposable Cartridge Syringe	Rocket Medical Plc	2005	0
K980238	Gynex Extended Reach Needle	Gynex Corp.	1998	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, K021224 (Wallach Surgical Devices, Inc., 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All HEE devices

HEE Set, Anesthesia, Paracervical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HEE

FDA has decided no HEE device since 2007.

Median 510(k) review, days · HEE

Too few HEE 510(k)s in any year since 2007 to give a median.

Recalls per year · HEE

1in 2015

2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HEE

3in 2022

2007high 5 (2017) · low 0 (2008)2025

MAUDE reports naming product code HEE, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	1
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	1	0
2016	—	0	1
2017	—	0	5
2018	—	0	1
2019	—	0	3
2020	—	0	0
2021	—	0	1
2022	—	0	3
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

https://510kreport.com/device/K910252 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910252: Potocky Neddle (TM) Disposable Injection Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910252

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