Cleared Traditional

CONVERTORS STERILIZATION WRAP (K921243) - FDA 510(k) Clearance

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

K921243 · Baxter Healthcare Corp · General Hospital
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Oct 1992
Decision
229d
Days
Class 2
Risk

K921243 is an FDA 510(k) clearance for the CONVERTORS STERILIZATION WRAP. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Waukegan, US). The FDA issued a Cleared decision on October 28, 1992 after a review of 229 days - an extended review 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: 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K921243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1992
Decision Date October 28, 1992
Days to Decision 229 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 129d · This submission: 229d
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 83
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K921243.
REUSABLE STERILCONTAINER FILTER MODEL #JK090
K041623 · Aesculap, Inc. · Dec 2004
MEDLINE STERILIZATION WRAP
K002968 · Medline Industries, Inc. · Jan 2001
ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY
K935238 · Sherwood Medical Co. · Feb 1994
STERILE O.R. BASIN KIT PRODUCT LINE
K841484 · Medline Industries, Inc. · Jul 1984
STERI-LOK DUAL PURPOSE PACKAGING/8400
K811670 · 3M Company · Jul 1981
STERILIZER WRAP
K770514 · C.R. Bard, Inc. · Apr 1977