510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962649Substantially Equivalent

Sportrol Rapid Sterility Indicator

North American Science Assoc., Inc., Northwood OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962649 is the FDA 510(k) clearance record for SPORTROL RAPID STERILITY INDICATOR, a class II device, cleared for North American Science Assoc., Inc. on under FDA product code MTC (Indicator, Chemical, Enzymatic, Sterilization Process). FDA records list 6 510(k) clearances for North American Science Assoc., Inc., from to . As of , FDA records show no recalls naming K962649.

Clearance record

Decision date
Received
(445 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
North American Science Assoc., Inc. 2261 Tracy Rd., Northwood OH
510(k) summary
Statement
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