Cleared Traditional

K914932 - SUTURE REMOVAL KIT

K914932 is an FDA 510(k) clearance for SUTURE REMOVAL KIT, manufactured by Westmark Hospital Supplies. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K914932 · Westmark Hospital Supplies · General Hospital
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Jan 1992
Decision
88d
Days
Class 2
Risk

K914932 is an FDA 510(k) clearance for the SUTURE REMOVAL KIT. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Westmark Hospital Supplies (Grand Rapids, US). The FDA issued a Cleared decision on January 31, 1992 after a review of 88 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 Westmark Hospital Supplies devices

FDA 510(k) Submission Details - K914932

510(k) Number K914932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 04, 1991
Decision Date January 31, 1992
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
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 125
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K914932.
ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY
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CONVERTORS STERILIZATION WRAP
K921243 · Baxter Healthcare Corp · Oct 1992
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
KIMGUARD PROCEDURE TRAY
K852203 · Kimberly-Clark Corp. · Jun 1985
ABCO INSTRUMENT PACKS & TRAYS
K851315 · Abco Dealers, Inc. · May 1985