510(k) · Cleared

Cleared

H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)

K953034510(k) TraditionalCleared Aug 29, 199571-day reviewClass II21 CFR 884.4530

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

Ackrad Laboratories · LKF Cannula, Manipulator/Injector, Uterine

Cleared on Aug 29, 1995 after a 71-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it.

Decided: Aug 29, 1995
Review: 71 days
Class: Class II
Product code: LKF
Recalls: None
Predicates: 0

20 later devices descend from it, 2 citing it directly.

This deviceK953034 H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories · 1995
Descendant · cites it directly · 12 of its ownK020951 H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model…Ackrad Laboratories · 2002 · Recalled
Descendant · 2 generations on · 7 of its ownK032835 H/S Catheter SetCatheter Research, Inc. · 2003 · Recalled
Descendant · cites it directly · 6 of its ownK961752 H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories · 1996 · Recalled
Descendant · 2 generations on · 5 of its ownK013972 H/S Elliptosphere Catheter Set, Model 61-4005Ackard Laboratories · 2001 · Recalled
Descendant · 3 generations on · 3 of its ownK123258 The Advance Catheter for HSG and SisCatheter Research, Inc. · 2013

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

1996high 2 (2002) · low 0 (1997)2026

Most influential descendants

Showing 5 of 20 · See all

K020951H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007Ackrad Laboratories · 2002 · cites it directly12descendants
K032835H/S Catheter SetCatheter Research, Inc. · 2003 · 2 generations on7descendants
K961752H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)Ackrad Laboratories · 1996 · cites it directly6descendants
K013972H/S Elliptosphere Catheter Set, Model 61-4005Ackard Laboratories · 2001 · 2 generations on5descendants
K123258The Advance Catheter for HSG and SisCatheter Research, Inc. · 2013 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K953034	H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)	Ackrad Laboratories	1995	—
+1	K020951	H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007	Ackrad Laboratories	2002	1
+2	K032835	H/S Catheter Set	Catheter Research, Inc.	2003	1
+1	K961752	H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)	Ackrad Laboratories	1996	2
+2	K013972	H/S Elliptosphere Catheter Set, Model 61-4005	Ackard Laboratories	2001	2
+3	K123258	The Advance Catheter for HSG and Sis	Catheter Research, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2001	1	0
2002	2	0
2003	1	0
2006	1	0
2007	1	0
2009	1	0
2010	1	0
2012	1	0
2013	2	0
2015	1	0
2016	1	0
2017	2	0
2018	2	0
2019	1	0
2022	1	0

FIG. 1 — Lineage of K953034, 1995–2022Source: 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 LKF? 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 LKF device

#1 K241693 FemChec Controlled Saline-Air Device (FCD-250)score 11.6 · 3 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?

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

What descends from it? (20)

See all 20

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

Number	Device	Applicant	Decided	Descendants
K020951	H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007	Ackrad Laboratories	2002	12
K961752	H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)	Ackrad Laboratories	1996	6

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, K020951 (Ackrad Laboratories, 2002) has gone furthest, with 12 descendants of its own.

How does its category compare?

All LKF devices

LKF Cannula, Manipulator/Injector, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LKF

2in 2025

2007high 6 (2010) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LKF

136in 2024

2007high 267 (2018) · low 79 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LKF

3in 2022

2007high 3 (2022) · low 0 (2007)2026

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

Adverse event reports per year · LKF

95in 2025

2007high 189 (2021) · low 23 (2018)2025

MAUDE reports naming product code LKF, 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	3	141	0	36
2008	0	—	2	59
2009	2	—	0	53
2010	6	178	0	46
2011	3	187	0	98
2012	0	—	2	104
2013	3	266	0	53
2014	3	169	0	45
2015	5	140	0	53
2016	1	—	0	62
2017	1	—	0	64
2018	4	267	0	23
2019	1	—	0	76
2020	0	—	0	119
2021	0	—	0	189
2022	4	79	3	100
2023	0	—	0	88
2024	3	136	0	125
2025	2	—	0	95
2026	0	—	0	—

https://510kreport.com/device/K953034 · printed Nov 6, 2026

Cite this page

510(k) Report. “K953034: H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953034

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Record history

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