Cleared Traditional

K931669 - CARAPACE DEBRIDEMENT KITS

K931669 is an FDA 510(k) clearance for CARAPACE DEBRIDEMENT KITS, manufactured by Carapace, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K931669 · Carapace, Inc. · General Hospital
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Feb 1994
Decision
307d
Days
Class 2
Risk

K931669 is an FDA 510(k) clearance for the CARAPACE DEBRIDEMENT KITS. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Carapace, Inc. (Broken Arrow, US). The FDA issued a Cleared decision on February 7, 1994 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Carapace, Inc. devices

FDA 510(k) Submission Details - K931669

510(k) Number K931669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received April 06, 1993
Decision Date February 07, 1994
Days to Decision 307 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 129d · This submission: 307d
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 149
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K931669.
SUTURE REMOVAL TRAY
K935683 · Cush Medical Products · Feb 1994
TRACHEOSTOMY CARE TRAY
K935685 · Cush Medical Products · Feb 1994
SKIN SCRUB TRAY
K935742 · Cush Medical Products · Feb 1994
WRAPPEL T
K923408 · Standard Textile Co., Inc. · Apr 1993
CONVERTORS STERILIZATION WRAP
K921243 · Baxter Healthcare Corp · Oct 1992
DRESSING CHANG & WOUND MANAGEMENT
K920480 · Cypress Medical Products, Ltd. · Oct 1992