510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854514Substantially Equivalent

Ambi-24 Ph/pressure Monitor

Biosearch Medical Products, Inc., Somerville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854514 is the FDA 510(k) clearance record for AMBI-24 PH/PRESSURE MONITOR, a class I device, cleared for Biosearch Medical Products, Inc. on under FDA product code FFT (Electrode, Ph, Stomach). FDA records list 70 510(k) clearances for Biosearch Medical Products, Inc., from to . As of , FDA records show no recalls naming K854514.

Clearance record

Decision date
Received
(104 days to decision)
Product code
FFT Electrode, Ph, Stomach
Regulation
21 CFR 876.1400
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Biosearch Medical Products, Inc. 35 Industrial Pkwy., Somerville NJ
Third party review
No

Clearances, product code FFT

Trailing 12 months

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

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