Cleared Traditional

swiftPro System (K222388) - FDA 510(k) Clearance

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

K222388 · Emblation , Ltd. · General & Plastic Surgery device
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May 2023
Decision
269d
Days
Class 2
Risk

K222388 is an FDA 510(k) clearance for the swiftPro System. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Emblation , Ltd. (Alloa, GB). The FDA issued a Cleared decision on May 4, 2023 after a review of 269 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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 Emblation , Ltd. devices

Submission Details

510(k) Number K222388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2022
Decision Date May 04, 2023
Days to Decision 269 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
154d slower than avg
Panel avg: 115d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NEY System, Ablation, Microwave And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 Consultant

Blackwell Device Consulting
Angela Blackwell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NEY System, Ablation, Microwave And Accessories

All 36
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K222388.
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