510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210481Substantially Equivalent

Instant 20s Indicator

True Indicating LLC, Toledo OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210481 is the FDA 510(k) clearance record for Instant 20s Indicator, a class II device, cleared for True Indicating, LLC on under FDA product code MTC (Indicator, Chemical, Enzymatic, Sterilization Process). FDA records list 6 510(k) clearances for True Indicating, LLC, from to . As of , FDA records show no recalls naming K210481.

Clearance record

Decision date
Received
(298 days to decision)
Product code
MTC Indicator, Chemical, Enzymatic, Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
True Indicating, LLC 946 Kane St., Toledo OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MTC

Trailing 12 months

FDA records hold no clearances under product code MTC in the trailing twelve months.

FDA records show no clearances under product code MTC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MTC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260