Cleared Traditional

K222240 - EXPLORER AIR® II (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222240 · Surgvision GmbH · General & Plastic Surgery device
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Feb 2023
Decision
217d
Days
Class 2
Risk

K222240 is an FDA 510(k) clearance for the EXPLORER AIR® II. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Surgvision GmbH (Munich, DE). The FDA issued a Cleared decision on February 28, 2023 after a review of 217 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 892.1600 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgvision GmbH devices

Submission Details

510(k) Number K222240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2022
Decision Date February 28, 2023
Days to Decision 217 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
103d slower than avg
Panel avg: 114d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 196
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K222240.
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K231986 · Synaptive Medical, Inc. · Mar 2024
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