Cleared Traditional

K150563 - Marrow Cellution Bone Marrow Aspiration...

K150563 is the FDA 510(k) clearance for Marrow Cellution Bone Marrow Aspiration... by Ranfac, Corp.. It is a Class 2 Gastroenterology & Urology device (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)
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.

View all Ranfac, Corp. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 111
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K150563.
Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
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K143546 · Stryker Corporation · Mar 2015
IVAS 8 GAUGE BONE BIOPSY KIT
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ENCOR ENSPIRE BREAST BIOPSY SYSTEM
K111100 · C.R. Bard, Inc. · Jun 2011