Cleared Traditional

K770514 - STERILIZER WRAP

K770514 is the FDA 510(k) clearance for STERILIZER WRAP by C.R. Bard, Inc.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K770514 · C.R. Bard, Inc. · General Hospital
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Apr 1977
Decision
21d
Days
Class 2
Risk

K770514 is an FDA 510(k) clearance for the STERILIZER WRAP. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 7, 1977 after a review of 21 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K770514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1977
Decision Date April 07, 1977
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
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 118
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K770514.
ALOFT STERILIZATION WRAP
K803306 · American Hospital Supply Corp. · Feb 1981
GUARDIAN STERILIZATION WRAP
K803294 · Kimberly-Clark Corp. · Feb 1981
GUARDIAN PEEL POUCHES
K803293 · Kimberly-Clark Corp. · Jan 1981
STERIL.WRAP(#221901,2,3,4,5,6,7,8,9)
K760662 · C.R. Bard, Inc. · Dec 1976
STERILIZER WRAP (CAT#221831,2,3,4,5,6)
K760661 · C.R. Bard, Inc. · Dec 1976