510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964337Substantially Equivalent

Better-Bladder (Bb)

Circulatory Technology, Inc., Oyster Bay NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964337 is the FDA 510(k) clearance record for BETTER-BLADDER (BB), a class II device, cleared for Circulatory Technology, Inc. on under FDA product code FIB (Protector, Transducer, Dialysis). FDA records list 9 510(k) clearances for Circulatory Technology, Inc., from to . As of , FDA records show no recalls naming K964337.

Clearance record

Decision date
Received
(204 days to decision)
Product code
FIB Protector, Transducer, Dialysis
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Circulatory Technology, Inc. 21 Singworth St., Oyster Bay NY
510(k) summary
Statement
Third party review
No

Clearances, product code FIB

Trailing 12 months

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

FDA records show no clearances under product code FIB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FIB, 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