Cleared Traditional

K223932 - SafeAir combi (SFR-combi-US)

K223932 is an FDA 510(k) clearance for SafeAir combi (SFR-combi-US), manufactured by Lina Medical Aps. The device is a Class 2 General Hospital device with product code GEI cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K223932 · Lina Medical Aps · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 2023
Decision
117d
Days
Class 2
Risk

K223932 is an FDA 510(k) clearance for the SafeAir combi (SFR-combi-US). Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Lina Medical Aps (Glostrup, DK). The FDA issued a Cleared decision on April 26, 2023 after a review of 117 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4400 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Lina Medical Aps devices

FDA 510(k) Submission Details - K223932

510(k) Number K223932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2022
Decision Date April 26, 2023
Days to Decision 117 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 129d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1266
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