510(k) · Cleared

Recalled · Class II · 2019

Stryker Heated Insufflator Tube Set

K003792510(k) TraditionalCleared Feb 21, 200175-day reviewClass II21 CFR 884.1730Recalls 1

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

Stryker Corp. · HIF Insufflator, Laparoscopic

Cleared on Feb 21, 2001 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 46 devices in its family, counting itself, have a Class I recall. 45 later devices descend from it. It has been recalled once.

Decided: Feb 21, 2001
Review: 75 days
Class: Class II
Product code: HIF
Recalls: 1
Predicates: 0

45 later devices descend from it, 1 citing it directly. 2 of the 46 devices in this family, counting this one, have a Class I recall.

This deviceK003792 Stryker Heated Insufflator Tube SetStryker Corp. · 2001
Descendant · cites it directly · 44 of its ownK063367 45L Core Insufflator, Model F114W.O.M. World of Medicine AG · 2007 · Recalled
Descendant · 2 generations on · 35 of its ownK103692 Sugiquest Airsealoptical Trocar & Cannula System with Integrated…Surgiquest, Inc. · 2011
Descendant · 2 generations on · 32 of its ownK110294 High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · Recalled (Class I)
Descendant · 3 generations on · 31 of its ownK122180 High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · Recalled (Class I)
Descendant · 3 generations on · 27 of its ownK143404 SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · Recalled

Showing 5 of 45 descendants. See all descendants

Descendants cleared per year

2007high 7 (2025) · low 0 (2008)2026

Class I recalls in this family

K110294 High Flow Insufflation Unit Uhi-42 generations on · 2011
K122180 High Flow Insufflantion Unit3 generations on · 2012

Most influential descendants

Showing 5 of 45 · See all

K06336745L Core Insufflator, Model F114W.O.M. World of Medicine AG · 2007 · cites it directly44descendants
K103692Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000Surgiquest, Inc. · 2011 · 2 generations on35descendants
K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · 2 generations on32descendants
K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 3 generations on31descendants
K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · 3 generations on27descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003792	Stryker Heated Insufflator Tube Set	Stryker Corp.	2001	—
+1	K063367	45L Core Insufflator, Model F114	W.O.M. World of Medicine AG	2007	4
+2	K103692	Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator…	Surgiquest, Inc.	2011	—
+2	K110294	High Flow Insufflation Unit Uhi-4	Olympus Medical Systems Corporation	2011	Class I
+3	K122180	High Flow Insufflantion Unit	Olympus Medical Systems Corporation	2012	Class I
+3	K143404	SurgiQuest AirSeal iFS System	Surgiquest, Inc.	2015	11

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2011	2	1
2012	4	1
2013	3	0
2014	1	0
2015	1	0
2016	1	0
2017	3	0
2018	1	0
2019	2	0
2020	3	0
2021	1	0
2023	4	0
2024	4	0
2025	7	0
2026	7	0

FIG. 1 — Lineage of K003792, 2001–2026Source: 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.

2 devices in this family have a Class I recall. 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 HIF device

#1 K250388 Endoflator +score 15.8 · 10 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? (45)

See all 45

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

Number	Device	Applicant	Decided	Descendants
K063367	45L Core Insufflator, Model F114	W.O.M. World of Medicine AG	2007	44

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 7, 2019	Class II	Z-1728-2019	Under Investigation by firm	The heated tube sets were consistently leaking and detaching from the cassette.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K063367 (W.O.M. World of Medicine AG, 2007) has gone furthest, with 44 descendants of its own.

How does its category compare?

All HIF devices

HIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HIF

3in 2025

2007high 7 (2023) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HIF

210in 2025

2007high 265 (2026) · low 64 (2020)2026

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

Recalls per year · HIF

12so far in 2026, the most since 2007

2007high 12 (2026) · low 0 (2007)2026

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

Adverse event reports per year · HIF

1,507in 2025

2007high 1,507 (2025) · low 8 (2007)2025

MAUDE reports naming product code HIF, 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	4	140	0	8
2008	2	—	1	14
2009	4	191	0	21
2010	2	—	0	41
2011	5	128	0	44
2012	5	138	0	38
2013	2	—	0	40
2014	2	—	0	43
2015	2	—	0	30
2016	3	88	1	72
2017	5	242	0	68
2018	3	207	1	97
2019	2	—	0	128
2020	4	64	0	360
2021	1	—	0	654
2022	1	—	0	667
2023	7	134	1 (1)	890
2024	4	170	0	1,483
2025	3	210	0	1,507
2026	3	265	12	—

https://510kreport.com/device/K003792 · printed Nov 5, 2026

Cite this page

510(k) Report. “K003792: Stryker Heated Insufflator Tube Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003792

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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