Cleared Traditional

Explorer Air II (K214097) - FDA 510(k) Clearance

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

K214097 · Surgvision GmbH · General & Plastic Surgery device
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Feb 2022
Decision
59d
Days
Class 2
Risk

K214097 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 25, 2022 after a review of 59 days - a notably fast clearance 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: 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 Surgvision GmbH devices

Submission Details

510(k) Number K214097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2021
Decision Date February 25, 2022
Days to Decision 59 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
56d faster than avg
Panel avg: 115d · This submission: 59d
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 55
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K214097.
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