Cleared Traditional

K150563 - Marrow Cellution Bone Marrow Aspiration Needle

K150563 is an FDA 510(k) clearance for Marrow Cellution Bone Marrow Aspiration..., manufactured by Ranfac, Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K150563 · Ranfac, Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
77d
Days
Class 2
Risk

K150563 is an FDA 510(k) clearance for the Marrow Cellution Bone Marrow Aspiration Needle. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Ranfac, Corp. (Avon, US). The FDA issued a Cleared decision on May 22, 2015 after a review of 77 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K150563

510(k) Number K150563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2015
Decision Date May 22, 2015
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 131d · This submission: 77d
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 362
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K150563.
Sertera Biopsy Device
K150169 · Hologic, Inc. · Aug 2015
Evacore Fully Disposable Vacuum Assist Biopsy Device
K150088 · Pin-Point Care Corp. · Jul 2015
Morrison Steerable Needle
K150625 · Apriomed AB · Jun 2015
Intraosseous Cannula System Bio-MAC¿ and Bio-CORE
K141910 · Biologic Therapies, Inc. · May 2015
Imbibe Aspirating XIA Taps
K143546 · Stryker Corporation · Mar 2015
Spectra Soft Tissue Biopsy Needles
K142791 · Spectra Medical Devices · Jan 2015
K150563 · Marrow Cellution Bone Marrow Aspiration Needle
Download PDF FDA Summary Ranfac, Corp.