Cleared Traditional

K972698 - TOF-WATCH

K972698 is an FDA 510(k) clearance for TOF-WATCH, manufactured by Organon Teknika Corp.. The device is a Class 2 Anesthesiology device with product code KOI cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K972698 · Organon Teknika Corp. · Anesthesiology device
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Dec 1997
Decision
151d
Days
Class 2
Risk

K972698 is an FDA 510(k) clearance for the TOF-WATCH. Classified as Stimulator, Nerve, Peripheral, Electric (product code KOI), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on December 16, 1997 after a review of 151 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2775 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Organon Teknika Corp. devices

FDA 510(k) Submission Details - K972698

510(k) Number K972698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1997
Decision Date December 16, 1997
Days to Decision 151 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 140d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOI Device Classification - Class 2, Special Controls

Product Code KOI Stimulator, Nerve, Peripheral, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2775
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - KOI Stimulator, Nerve, Peripheral, Electric

All 22
Devices cleared under the same product code (KOI) and FDA review panel - the closest regulatory comparables to K972698.
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