Cleared Traditional

K970152 - BIOPSY TRAY

K970152 is an FDA 510(k) clearance for BIOPSY TRAY, manufactured by Medcare Medical Group, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K970152 · Medcare Medical Group, Inc. · General Hospital
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Mar 1997
Decision
48d
Days
Class 2
Risk

K970152 is an FDA 510(k) clearance for the BIOPSY TRAY. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Medcare Medical Group, Inc. (East Swanzey, US). The FDA issued a Cleared decision on March 5, 1997 after a review of 48 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital 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 Medcare Medical Group, Inc. devices

FDA 510(k) Submission Details - K970152

510(k) Number K970152 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 16, 1997
Decision Date March 05, 1997
Days to Decision 48 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 129d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 Hospital devices follow this clearance model.

Regulatory Peers - FRG Wrap, Sterilization

All 187
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K970152.
CARR RIGID CONTAINER SYSTEM
K972138 · Carr Metal Products, Inc. · Nov 1997
SECURE-WRAP (TM) STERILIZATION WRAP
K971483 · American Threshold Industries, Inc. · Jun 1997
PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)
K962605 · Surgicot, Inc. · Mar 1997
CPR DRESSING CHANGE TRAY
K960206 · Custom Pack Reliability · Apr 1996
CPR ORTHO HAND PACK
K960210 · Custom Pack Reliability · Apr 1996
CPR TOTAL KNEE PACK
K960211 · Custom Pack Reliability · Apr 1996