Cleared Traditional

K262531 - OnControl Powered Bone Access Systems

Also marketed or referenced as:
OnControl Bone Marrow Aspiration System OnControl Bone Marrow Biopsy System OnControl Bone Lesion Biopsy System OnControl Power Driver

K262531 is an FDA 510(k) clearance for OnControl Powered Bone Access Systems, manufactured by Teleflex Medical, LLC. The device is a Class 2 General & Plastic Surgery device with product code KNW cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K262531 · Teleflex Medical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
97d
Days
Class 2
Risk

K262531 is an FDA 510(k) clearance for the OnControl Powered Bone Access Systems. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Teleflex Medical, LLC (Morrisville, US). The FDA issued a Cleared decision on October 27, 2026 after a review of 97 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K262531

510(k) Number K262531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2026
Decision Date October 27, 2026
Days to Decision 97 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
18d faster than avg
Panel avg: 115d · This submission: 97d
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 365
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K262531.
Automatic Core Biopsy Instrument
K260517 · Zhejiang Curaway Medical Technology Co., Ltd. · Aug 2026
EnCor EnCompass™ Breast Biopsy and Tissue Removal System
K262571 · Bard Peripheral Vascular, Inc. · Aug 2026
Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)
K262792 · Hologic, Inc. · Aug 2026
Marrow Marxman
K260572 · Medimetrix, LLC · Aug 2026
Promisemed VeriEcto Automatic Biopsy Needles
K261196 · Promisemed Hangzhou Meditech Co., Ltd. · May 2026
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module
K260365 · Devicor Medical Products, Inc. · Mar 2026
K262531 · OnControl Powered Bone Access Systems
Download PDF FDA Summary Teleflex Medical, LLC