510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K974415Substantially Equivalent

Kimberly-Clark Gas Plasma Sterilization Indicator Strip

Kimberly-Clark Corporation, Roswell GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974415 is the FDA 510(k) clearance record for KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP, a class II device, cleared for Kimberly-Clark Corp. on under FDA product code JOJ (Indicator, Physical/Chemical Sterilization Process). FDA records list 122 510(k) clearances for Kimberly-Clark Corp., from to . As of , FDA records show no recalls naming K974415.

Clearance record

Decision date
Received
(228 days to decision)
Product code
JOJ Indicator, Physical/Chemical Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Kimberly-Clark Corp. 1400 Holcomb Bridge Rd., Roswell GA
510(k) summary
Summary
Third party review
No

Clearances, product code JOJ

Trailing 12 months
4 clearances under product code JOJ in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JOJ, trailing twelve months
MonthClearances
December 20251
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20261
November 20260