Cleared Traditional

K852335 - STERILIZATION CONTAINER

K852335 is an FDA 510(k) clearance for STERILIZATION CONTAINER, manufactured by Bemis Mfg. Co.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K852335 · Bemis Mfg. Co. · General Hospital
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Sep 1985
Decision
108d
Days
Class 2
Risk

K852335 is an FDA 510(k) clearance for the STERILIZATION CONTAINER. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Bemis Mfg. Co. (Sheboygan Falls, US). The FDA issued a Cleared decision on September 16, 1985 after a review of 108 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Bemis Mfg. Co. devices

FDA 510(k) Submission Details - K852335

510(k) Number K852335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1985
Decision Date September 16, 1985
Days to Decision 108 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
21d faster than avg
Panel avg: 129d · This submission: 108d
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 189
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K852335.
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