Cleared Traditional

K202012 - Mammotome Revolve Dual Vacuum Assisted ...

K202012 is the FDA 510(k) clearance for Mammotome Revolve Dual Vacuum Assisted ... by Devicor Medical Products, Inc.. It is a Class 2 General & Plastic Surgery device (product code KNW) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K202012 · Devicor Medical Products, Inc. · General & Plastic Surgery device
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Aug 2020
Decision
28d
Days
Class 2
Risk

K202012 is an FDA 510(k) clearance for the Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Devicor Medical Products, Inc. (Cincinnati, US). The FDA issued a Cleared decision on August 18, 2020 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1075 - 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 Devicor Medical Products, Inc. devices

Submission Details

510(k) Number K202012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2020
Decision Date August 18, 2020
Days to Decision 28 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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

Regulatory Technology Services, LLC
Prithul Bom

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 - KNW Instrument, Biopsy

All 160
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K202012.
Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm
K203397 · Biopsybell S.R.L. · Jan 2021
Ran-Flex-B Bone Marrow Aspiration Needle
K202287 · Ranfac Corporation · Sep 2020
Temno Elite Biopsy System
K201166 · Merit Medical Systems, Inc. · Aug 2020
Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices
K201244 · Transmed7, LLC · Aug 2020
MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System
K192099 · Medax Srl Unipersonale · Apr 2020
Medone Ultra, Medextra
K192101 · Medax Srl Unipersonale · Apr 2020

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.