Cleared Traditional

K252438 - Explant Express

K252438 is an FDA 510(k) clearance for Explant Express, manufactured by Applied Medical Technology, Inc.. The device is a Class 2 General & Plastic Surgery device with product code QVS cleared through the Traditional 510(k) pathway after a 186-day FDA review.

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

FDA 510(k) Submission Details - K252438

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
71d slower than avg
Panel avg: 115d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QVS Device Classification - Class 2, Special Controls

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.