Cleared Traditional

K142377 - The OnControl Bone Marrow Biopsy System...

K142377 is an FDA 510(k) clearance for The OnControl Bone Marrow Biopsy System..., manufactured by Vidacare, LLC. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K142377 · Vidacare, LLC · Gastroenterology & Urology device
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Dec 2014
Decision
113d
Days
Class 2
Risk

K142377 is an FDA 510(k) clearance for the The OnControl Bone Marrow Biopsy System by Vidacare. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Vidacare, LLC (Shavano Park, US). The FDA issued a Cleared decision on December 17, 2014 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vidacare, LLC devices

FDA 510(k) Submission Details - K142377

510(k) Number K142377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2014
Decision Date December 17, 2014
Days to Decision 113 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 130d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 174
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K142377.
Corvocet Biopsy System
K153337 · Merit Medical Systems, Inc. · Mar 2016
Sertera Biopsy Device
K150169 · Hologic, Inc. · Aug 2015
Imbibe Aspirating XIA Taps
K143546 · Stryker Corporation · Mar 2015
ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS
K141552 · Care Fusion · Sep 2014
IVAS 8 GAUGE BONE BIOPSY KIT
K141673 · Stryker Corporation · Sep 2014
BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT
K133948 · Bard Peripheral Vascular, Inc. · Feb 2014