510(k) · Cleared

Cleared

Insuflow Synergy Port, Insuflow Synergy XL Port

K140263510(k) SpecialCleared Mar 5, 201430-day reviewClass II21 CFR 884.1730

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

Lexion Medical, LLC · HIF Insufflator, Laparoscopic

Cleared on Mar 5, 2014 as substantially equivalent to K120640 (Lexion Medical, LLC, 2012) and 3 other predicates after a 30-day review. Its family tree reaches back 8 generations to 1997. 2 later devices descend from it.

Decided: Mar 5, 2014
Review: 30 days
Class: Class II
Product code: HIF
Recalls: None
Predicates: 4

Its longest line of descent runs back 8 generations to K964171 (1997). 36 ancestors in all, the oldest K903419 (1990). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 8 generations backK964171 Vasoview Balloon Dissection SystemOrigin Medsystems, Inc. · 1997
7 generations backK981700 Vasoview Dissection/Vessel Harvesting SystemOrigin Medsystems, Inc. · 1998
6 generations backK030512 Guidant Vasoview Endoscopic Vessel Harvesting SystemGuidant Corp. · 2003 · Recalled
5 generations backK060723 40 L High Flow Insufflator F113W.O.M. World of Medicine AG · 2006
4 generations backK063367 45L Core Insufflator, Model F114W.O.M. World of Medicine AG · 2007 · Recalled
3 generations backK103692 Sugiquest Airsealoptical Trocar & Cannula System with Integrated…Surgiquest, Inc. · 2011
2 generations backK120640 Insuflow Synergy PortLexion Medical, LLC · 2012
1 generation backK132204 Insuflow Synergy XL PortLexion Medical, LLC · 2013
This deviceK140263 Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC · 2014
Descendant · cites it directly · 1 of its ownK170799 AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC · 2017
Descendant · 2 generations on · 0 of its ownK191780 AP50/30 Insufflator with Insuflow PortLexion Medical, LLC · 2019

Most influential descendants

Showing 2 of 2 · See all

K170799AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC · 2017 · cites it directly1descendant
K191780AP50/30 Insufflator with Insuflow PortLexion Medical, LLC · 2019 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K964171	Vasoview Balloon Dissection System	Origin Medsystems, Inc.	1997	—
−7	K981700	Vasoview Dissection/Vessel Harvesting System	Origin Medsystems, Inc.	1998	—
−6	K030512	Guidant Vasoview Endoscopic Vessel Harvesting System	Guidant Corp.	2003	1
−5	K060723	40 L High Flow Insufflator F113	W.O.M. World of Medicine AG	2006	—
−4	K063367	45L Core Insufflator, Model F114	W.O.M. World of Medicine AG	2007	4
−3	K103692	Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator…	Surgiquest, Inc.	2011	—
−2	K120640	Insuflow Synergy Port	Lexion Medical, LLC	2012	—
−1	K132204	Insuflow Synergy XL Port	Lexion Medical, LLC	2013	—
0 (this device)	K140263	Insuflow Synergy Port, Insuflow Synergy XL Port	Lexion Medical, LLC	2014	—
+1	K170799	AP 50/30 Insufflator with Insuflow Port	Lexion Medical, LLC	2017	—
+2	K191780	AP50/30 Insufflator with Insuflow Port	Lexion Medical, LLC	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1991	2	0
1992	1	0
1993	1	0
1994	1	0
1995	2	0
1996	2	0
1998	1	0
1999	1	0
2000	1	0
2001	1	0
2003	4	0
2004	1	0
2006	2	0
2007	3	0
2008	1	0
2009	2	0
2012	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0
2019	1	0

FIG. 1 — Lineage of K140263, 1997–2019Source: 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 HIF? 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? (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
*	K120640	Insuflow Synergy Port Summary page 1 …s that the modified lnsuflow® SynergyTM and Synergy Tm XL Port devices are substantially equivalent to the following devices: * Insuflow® SynergyTM Port, K 120640 * Insuflow®SynrgyTM XL Port, K 132204 * EndoPath Xcel Trocar, K032676 * SurgiQues…	Lexion Medical, LLC	2012	—
*	K132204	Insuflow Synergy XL Port Summary page 1 …XL Port devices are substantially equivalent to the following devices: * Insuflow® SynergyTM Port, K 120640 * Insuflow®SynrgyTM XL Port, K 132204 * EndoPath Xcel Trocar, K032676 * SurgiQuest AirSeal, K121336 Description: The Insuflow® Synergy…	Lexion Medical, LLC	2013	—
*	K032676	Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar Summary page 1 …the following devices: * Insuflow® SynergyTM Port, K 120640 * Insuflow®SynrgyTM XL Port, K 132204 * EndoPath Xcel Trocar, K032676 * SurgiQuest AirSeal, K121336 Description: The Insuflow® SynergyTM and Synergy Tm XL Port devices are gas condit…	Ethicon Endo-Surgery, Inc.	2003	6
*	K121336	Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator… Summary page 1 …low® SynergyTM Port, K 120640 * Insuflow®SynrgyTM XL Port, K 132204 * EndoPath Xcel Trocar, K032676 * SurgiQuest AirSeal, K121336 Description: The Insuflow® SynergyTM and Synergy Tm XL Port devices are gas conditioning devices that attach to the outlet port…	Surgiquest, Inc.	2012	—

Also cleared against K120640: 2 other devices →

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
K170799	AP 50/30 Insufflator with Insuflow Port	Lexion Medical, LLC	2017	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?

The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
4 of the 36 ancestors have a recall of any class.
Of its descendants, K170799 (Lexion Medical, LLC, 2017) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K120640.

How does its category compare?

All HIF devices

HIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

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	—

What is it indicated for?

Insuflow® Synergy™ Port (5 mm) and Insuflow® Synergy™ XL Port (8 mm, 10 mm and 12 mm) have applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140263 · printed Nov 3, 2026

Cite this page

510(k) Report. “K140263: Insuflow Synergy Port, Insuflow Synergy XL Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K140263

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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