Cleared Traditional

K871798 - FILM AND PAPER COMBINATION STERILIZING BAG

K871798 is an FDA 510(k) clearance for FILM AND PAPER COMBINATION STERILIZING BAG, manufactured by Cost Rite Health Products, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K871798 · Cost Rite Health Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1987
Decision
75d
Days
Class 2
Risk

K871798 is an FDA 510(k) clearance for the FILM AND PAPER COMBINATION STERILIZING BAG. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Cost Rite Health Products, Inc. (Chatsworth, US). The FDA issued a Cleared decision on July 21, 1987 after a review of 75 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 Cost Rite Health Products, Inc. devices

FDA 510(k) Submission Details - K871798

510(k) Number K871798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1987
Decision Date July 21, 1987
Days to Decision 75 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
54d faster than avg
Panel avg: 129d · This submission: 75d
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 163
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K871798.
DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISP
K921490 · Trinity Laboratories, Inc. · Oct 1992
KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP
K881471 · Kimberly-Clark Corp. · Aug 1988
CENTRAL SUPPLY ROOM WRAP
K873175 · Ulti-Med Intl., Inc. · Sep 1987
KIMGUARD PROCEDURE TRAY
K852203 · Kimberly-Clark Corp. · Jun 1985
ABCO INSTRUMENT PACKS & TRAYS
K851315 · Abco Dealers, Inc. · May 1985
BLUE SEAL II STERILIZATION POUCH
K851340 · American Sterilizer Co. · Apr 1985