510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K972698Substantially Equivalent

Tof-Watch

bioMerieux, Inc., Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972698 is the FDA 510(k) clearance record for TOF-WATCH, a class II device, cleared for Organon Teknika Corp. on under FDA product code KOI (Stimulator, Nerve, Peripheral, Electric). FDA records list 408 510(k) clearances for BIOMERIEUX, INC., from to . As of , FDA records show no recalls naming K972698.

Clearance record

Decision date
Received
(151 days to decision)
Product code
KOI Stimulator, Nerve, Peripheral, Electric
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Applicant
Organon Teknika Corp. 100 Akzo Ave., Durham NC
510(k) summary
Summary
Third party review
No

Clearances, product code KOI

Trailing 12 months
1 clearance under product code KOI in the twelve months to November 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KOI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260