510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K910180Substantially Equivalent

Bacti-Swab

Remel Inc, Lenexa KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910180 is the FDA 510(k) clearance record for BACTI-SWAB, a class I device, cleared for Remel Co. on under FDA product code JSM (Culture Media, Non-Propagating Transport). FDA records list 107 510(k) clearances for Remel Co., from to . As of , FDA records show no recalls naming K910180.

Clearance record

Decision date
Received
(115 days to decision)
Product code
JSM Culture Media, Non-Propagating Transport
Regulation
21 CFR 866.2390
Device class
Class I
Review panel
Microbiology
Applicant
Remel Co. 12076 Santa Fe Dr., Lenexa KS
Third party review
No

Clearances, product code JSM

Trailing 12 months

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

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