Cleared Traditional

K971268 - BONE & MARROW CLLECTION SYSTEM

K971268 is an FDA 510(k) clearance for BONE & MARROW CLLECTION SYSTEM, manufactured by Biomedical International Corp.. The device is a Class 1 General & Plastic Surgery device with product code GEY cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K971268 · Biomedical International Corp. · General & Plastic Surgery device
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Jul 1997
Decision
87d
Days
Class 1
Risk

K971268 is an FDA 510(k) clearance for the BONE & MARROW CLLECTION SYSTEM. Classified as Motor, Surgical Instrument, Ac-powered (product code GEY), Class I - General Controls.

Submitted by Biomedical International Corp. (San Antonio, US). The FDA issued a Cleared decision on July 3, 1997 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - 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 Biomedical International Corp. devices

FDA 510(k) Submission Details - K971268

510(k) Number K971268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1997
Decision Date July 03, 1997
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

GEY Device Classification - Class 1, General Controls

Product Code GEY Motor, Surgical Instrument, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GEY Motor, Surgical Instrument, Ac-powered

All 25
Devices cleared under the same product code (GEY) and FDA review panel - the closest regulatory comparables to K971268.
MEDNEXT 1000 DRILL
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BONE AND MARROW COLLECTION SYSTEM KIT
K971782 · Biomedical Ent., Inc. · Jul 1997
ORTHOCHUCK
K964252 · Buckman Co., Inc. · May 1997
ANSPACH LUBRICATING SYSTEM II
K970530 · The Anspach Effort, Inc. · May 1997
BME BONE DRILL BITS
K964073 · Biomedical Ent., Inc. · Nov 1996