510(k) · Cleared

Cleared

SafeAir combi (SFR-combi-US)

K223932510(k) TraditionalCleared Apr 26, 2023117-day reviewClass II21 CFR 878.4400

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

Lina Medical Aps · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Apr 26, 2023 as substantially equivalent to K143161 (Covidien, 2014) after a 117-day review. Its family tree reaches back 2 generations to 1995.

Decided: Apr 26, 2023
Review: 117 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K944602 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK944602 Valleylab Force FXValleylab, Inc. · 1995
1 generation backK143161 Force FX-8(S), Force FX-8C (S), Force FX-8CA (S)Covidien · 2014
This deviceK223932 SafeAir combi (SFR-combi-US)Lina Medical Aps · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K944602	Valleylab Force FX	Valleylab, Inc.	1995	—
−1	K143161	Force FX-8(S), Force FX-8C (S), Force FX-8CA (S)	Covidien	2014	—
0 (this device)	K223932	SafeAir combi (SFR-combi-US)	Lina Medical Aps	2023	—

FIG. 1 — Lineage of K223932, 1995–2023Source: 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 GEI? 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 GEI device

#1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 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? (1)

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
*	K143161	Force FX-8(S), Force FX-8C (S), Force FX-8CA (S) Summary page 4 …ccessories Regulation Number: 21 CFR 878.4400, Class II Classification Product Code: GEI, FYD Predicate Device: K143161: Covidien Force FX Generators Reference Predicate: K182224: LiNA Medical Smoke Evacuator compact Device Description: S…	Covidien	2014	—
†	K182224	SafeAir Smoke Evacuator compact	Lina Medical Aps	2019	—

Also cleared against K143161: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 28 years and passes through 3 companies; a new generation was cleared every 19.5 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K143161.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

What is it indicated for?

The SafeAir Combi is an electrosurgical generator containing an integrated surgical smoke evacuator. The unit is intended to deliver high frequency energy for cutting and/or coagulating tissues using monopolar and bipolar tools in surgical procedures. When used with an electrosurgical pencil capable of surgical smoke evacuation, the console is also intended to remove and filtrate smoke generated during electrosurgical procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K223932 · printed Nov 4, 2026

Cite this page

510(k) Report. “K223932: SafeAir combi (SFR-combi-US).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223932

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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