Cleared Traditional

STERILIZATION WRAPS #620,624,648,640,636,630,612 (K863981) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K863981 · Graham Medical Products · General Hospital
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Nov 1986
Decision
42d
Days
Class 2
Risk

K863981 is an FDA 510(k) clearance for the STERILIZATION WRAPS #620,624,648,640,636,630,612. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Graham Medical Products (Holyoke, US). The FDA issued a Cleared decision on November 25, 1986 after a review of 42 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 Graham Medical Products devices

Submission Details

510(k) Number K863981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1986
Decision Date November 25, 1986
Days to Decision 42 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 129d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 88
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K863981.
G.E. STERILE PUNCTURE TRAY
K960202 · GE Medical Systems · Feb 1996
ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY
K935238 · Sherwood Medical Co. · Feb 1994
CONVERTORS STERILIZATION WRAP
K921243 · Baxter Healthcare Corp · Oct 1992
STERILE O.R. BASIN KIT PRODUCT LINE
K841484 · Medline Industries, Inc. · Jul 1984
STERI-LOK DUAL PURPOSE PACKAGING/8400
K811670 · 3M Company · Jul 1981
STERILIZER WRAP
K770514 · C.R. Bard, Inc. · Apr 1977