Cleared Traditional

EVA15 insufflator (K222901) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222901 · Palliare , Ltd. · Obstetrics & Gynecology device
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Jan 2023
Decision
126d
Days
Class 2
Risk

K222901 is an FDA 510(k) clearance for the EVA15 insufflator. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Palliare , Ltd. (Galway, IE). The FDA issued a Cleared decision on January 27, 2023 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Palliare , Ltd. devices

Submission Details

510(k) Number K222901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2022
Decision Date January 27, 2023
Days to Decision 126 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 160d · This submission: 126d
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIF Insufflator, Laparoscopic

All 47
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K222901.
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AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set
K211104 · Conmed Corporation · Aug 2021
EVA15
K202799 · Palliare , Ltd. · Oct 2020