Cleared Traditional

K252438 - Explant Express (FDA 510(k) Clearance)

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

K252438 · Applied Medical Technology, Inc. · General & Plastic Surgery device
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Feb 2026
Decision
186d
Days
Class 2
Risk

K252438 is an FDA 510(k) clearance for the Explant Express. Classified as Breast Implant Suction Retrieval Device (product code QVS), Class II - Special Controls.

Submitted by Applied Medical Technology, Inc. (Brecksville, US). The FDA issued a Cleared decision on February 3, 2026 after a review of 186 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4675 - 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 Applied Medical Technology, Inc. devices

Submission Details

510(k) Number K252438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2025
Decision Date February 03, 2026
Days to Decision 186 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
72d slower than avg
Panel avg: 114d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QVS Breast Implant Suction Retrieval Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4675
Definition A Breast Implant Suction Retrieval System Is A Prescription Surgical Device That Uses Vacuum Suction To Assist In The Removal And Containment Of A Ruptured Silicone Breast Implant.
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.