510(k) · Cleared

Cleared

Hydro-Flex LI Laparoscopic Irrigation System

K961224510(k) TraditionalCleared May 16, 199648-day reviewClass II21 CFR 876.1500

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

Davol Inc., Sub. C. R. Bard, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on May 16, 1996 as substantially equivalent to K902722 (Davol, Inc., 1990) and 3 other predicates after a 48-day review. Its family tree reaches back 1 generation to 1990. 3 later devices descend from it.

Decided: May 16, 1996
Review: 48 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K902722 (1990). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK902722 Bard Laparoscopic Irrigator Pump SystemDavol, Inc. · 1990
This deviceK961224 Hydro-Flex LI Laparoscopic Irrigation SystemDavol Inc., Sub. C. R. Bard, Inc. · 1996
Descendant · cites it directly · 2 of its ownK033573 Linvatec 10K Irrigation SystemLinvatec Corp. · 2004
Descendant · cites it directly · 1 of its ownK063326 Conmed Linvatec 24K Irrigation SystemConmed Linvatec · 2007
Descendant · 2 generations on · 0 of its ownK182882 CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable…Conmed Corporation · 2018

Most influential descendants

Showing 3 of 3 · See all

K033573Linvatec 10K Irrigation SystemLinvatec Corp. · 2004 · cites it directly2descendants
K063326Conmed Linvatec 24K Irrigation SystemConmed Linvatec · 2007 · cites it directly1descendant
K182882CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote ControlConmed Corporation · 2018 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K902722	Bard Laparoscopic Irrigator Pump System	Davol, Inc.	1990	—
0 (this device)	K961224	Hydro-Flex LI Laparoscopic Irrigation System	Davol Inc., Sub. C. R. Bard, Inc.	1996	—
+1	K033573	Linvatec 10K Irrigation System	Linvatec Corp.	2004	—
+1	K063326	Conmed Linvatec 24K Irrigation System	Conmed Linvatec	2007	—
+2	K182882	CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control	Conmed Corporation	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	2	0
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2007	1	0
2018	1	0

FIG. 1 — Lineage of K961224, 1990–2018Source: 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 GCJ? 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 GCJ device

#1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 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? (4)

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
*	K902722	Bard Laparoscopic Irrigator Pump System Summary page 1 …opic Irrigation System Common/Usual Name: Laparoscopic Irrigator Classification Name: Laparoscope, General & Plastic Surgery Predicate Device: - Davol Endo-Flo System (K902722) - U.S. Endoscopy Group'’s Laparoscopic Irrigation System and Laparoscopic Irrigation Tubing Set (K911493 and K911484) - Linvat…	Davol, Inc.	1990	—
*	K911493	Laparoscopic Irrigation Pump Summary page 1 …& Plastic Surgery Predicate Device: - Davol Endo-Flo System (K902722) - U.S. Endoscopy Group'’s Laparoscopic Irrigation System and Laparoscopic Irrigation Tubing Set (K911493 and K911484) - Linvatec Apex™ Universal Irrigation System (K933873) The HydroFlex LI system proposed in this submission is subs…	United States Endoscopy Group, Inc.	1991	—
*	K911484	Laparoscopic Suction Irrigation Tubing Set Summary page 1 …rgery Predicate Device: - Davol Endo-Flo System (K902722) - U.S. Endoscopy Group'’s Laparoscopic Irrigation System and Laparoscopic Irrigation Tubing Set (K911493 and K911484) - Linvatec Apex™ Universal Irrigation System (K933873) The HydroFlex LI system proposed in this submission is substantially eq…	United States Endoscopy Group, Inc.	1991	—
*	K933873	Concept Universal Pump System Summary page 1 …22) - U.S. Endoscopy Group'’s Laparoscopic Irrigation System and Laparoscopic Irrigation Tubing Set (K911493 and K911484) - Linvatec Apex™ Universal Irrigation System (K933873) The HydroFlex LI system proposed in this submission is substantially equivalent to Davol’s currently marketed Endo- Flo system…	Linvatec Corp.	1994	—

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K033573	Linvatec 10K Irrigation System	Linvatec Corp.	2004	2
K063326	Conmed Linvatec 24K Irrigation System	Conmed Linvatec	2007	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 4 ancestors has a recall.
Of its descendants, K033573 (Linvatec Corp., 2004) has gone furthest, with 2 descendants of its own.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, 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	18	42	12	1,639
2008	19	73	16	1,319
2009	21	85	6	1,995
2010	24	122	30	2,657
2011	15	113	9	2,133
2012	17	88	1	1,526
2013	15	93	7 (1)	1,565
2014	19	90	2	1,714
2015	26	76	0	1,710
2016	27	99	5	2,080
2017	20	77	1	3,468
2018	21	88	1	2,562
2019	15	60	0	2,578
2020	28	61	0	2,618
2021	18	116	0	3,431
2022	20	103	1	3,945
2023	31	109	1	6,002
2024	29	90	0	6,047
2025	21	108	5	5,860
2026	26	122	1	—

What is it indicated for?

The HydroFlex LI System is designed to provide controlled irrigation during laparoscopic procedures. The system helps flush blood and tissue debris from the operative site during laparoscopy to aid in visualization. It may also be used for dissection of filmy adhesions (i.e. hydrodissection), hydrodissolution of blood clot formations, and peritoneal lavage.

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/K961224 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961224: Hydro-Flex LI Laparoscopic Irrigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961224

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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