Cleared Traditional

K190303 - AirSeal

K190303 is the FDA 510(k) clearance for AirSeal by Conmed Corporation. It is a Class 2 General & Plastic Surgery device (product code HIF) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K190303 · Conmed Corporation · General & Plastic Surgery device
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Mar 2019
Decision
44d
Days
Class 2
Risk

K190303 is an FDA 510(k) clearance for the AirSeal. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on March 28, 2019 after a review of 44 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 884.1730 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Conmed Corporation devices

Submission Details

510(k) Number K190303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2019
Decision Date March 28, 2019
Days to Decision 44 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 115d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIF Insufflator, Laparoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1730
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - HIF Insufflator, Laparoscopic

All 80
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K190303.
EVA 15 Insufflator
K193520 · Palliare , Ltd. · Jul 2020
GTK Veress Needles
K193339 · Guangzhou T.K Medical Instrument Co., Ltd. · Jan 2020
AP50/30 Insufflator with Insuflow Port
K191780 · Lexion Medical, LLC · Aug 2019
GRI-Alleset Veress Needle
K172835 · Gri Medical and Electronic Technology Co., Ltd. · Jun 2018
SurgiQuest AIRSEAL iFS System
K172516 · Conmed Corporation · Mar 2018
TEMED Gas Diffuser
K173545 · Temed · Feb 2018