510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883234Substantially Equivalent

Tonomitor (Tm) + Sump

Tonometrics, Inc., Bethesda MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883234 is the FDA 510(k) clearance record for TONOMITOR (TM) + SUMP, a class I device, cleared for Tonometrics, Inc. on under FDA product code FFT (Electrode, Ph, Stomach). FDA records list 4 510(k) clearances for Tonometrics, Inc., from to . As of , FDA records show no recalls naming K883234.

Clearance record

Decision date
Received
(72 days to decision)
Product code
FFT Electrode, Ph, Stomach
Regulation
21 CFR 876.1400
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Tonometrics, Inc. 4903 Sangamore Rd., Bethesda MD
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