Cleared Traditional

CSR WRAP - CENTRAL SUPPLY ROOM WRAP FOR STERIL- (K844920) - FDA 510(k) Clearance

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

K844920 · Papeteries Depont-Audemer · General Hospital
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Apr 1985
Decision
103d
Days
Class 2
Risk

K844920 is an FDA 510(k) clearance for the CSR WRAP - CENTRAL SUPPLY ROOM WRAP FOR STERIL-. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Papeteries Depont-Audemer (France, FR). The FDA issued a Cleared decision on April 1, 1985 after a review of 103 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 Papeteries Depont-Audemer devices

Submission Details

510(k) Number K844920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1984
Decision Date April 01, 1985
Days to Decision 103 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
26d faster than avg
Panel avg: 129d · This submission: 103d
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 90
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K844920.
ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY
K935238 · Sherwood Medical Co. · Feb 1994
CONVERTORS STERILIZATION WRAP
K921243 · Baxter Healthcare Corp · Oct 1992
ABCO INSTRUMENT PACKS & TRAYS
K851315 · Abco Dealers, Inc. · May 1985
STERILE O.R. BASIN KIT PRODUCT LINE
K841484 · Medline Industries, Inc. · Jul 1984
ECONOMY LINE OF TRAYS
K820589 · Abco Dealers, Inc. · Apr 1982
STERI-LOK DUAL PURPOSE PACKAGING/8400
K811670 · 3M Company · Jul 1981