Cleared Traditional

K770797 - TRAY, CATHETERIZATION W/FOLEY, STERILE

K770797 is an FDA 510(k) clearance for TRAY, manufactured by Lukens Corp.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K770797 · Lukens Corp. · General Hospital
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Jul 1977
Decision
70d
Days
Class 2
Risk

K770797 is an FDA 510(k) clearance for the TRAY, CATHETERIZATION W/FOLEY, STERILE. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Lukens Corp. (Mchenry, US). The FDA issued a Cleared decision on July 11, 1977 after a review of 70 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 Lukens Corp. devices

FDA 510(k) Submission Details - K770797

510(k) Number K770797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1977
Decision Date July 11, 1977
Days to Decision 70 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
59d faster than avg
Panel avg: 129d · This submission: 70d
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 234
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K770797.
AUTOCLAVE POUCHES&ROLLS/STEAM&GAS
K780034 · E.M. Adams · Feb 1978
SUOGIPEEL PACKAGING SYSTEM
K771846 · Surgicot, Inc. · Oct 1977
POUCHES, PEEL OPEN, BREATHABLE
K771032 · Surgicot, Inc. · Jul 1977
STERILIZER WRAP
K770514 · C.R. Bard, Inc. · Apr 1977
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