Cleared Traditional

K972698 - TOF-WATCH (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K972698 · Organon Teknika Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 139d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
Devices cleared under the same product code (KOI) and FDA review panel - the closest regulatory comparables to K972698.
Neuromuscular Transmission Monitor TOF3D (2510091)
K250887 · MIPM Mammendorfer Institut f?r Physik und Medizin GmbH · Oct 2025
WiTOF
K243339 · Idmed · Jun 2025
iTOF®
K242525 · Nerbio Medical Software Platforms, Inc. · Dec 2024
Tetragraph Neuromuscular Transmission Monitor
K220530 · Senzime AB · Aug 2022
Life Scope PT BSM-1700 Series Bedside Monitor
K220976 · Nihon Kohden Corporation · Jul 2022
Neuromuscular Transmission Monitor TOF3D
K212434 · MIPM Mammendorfer Institut f?r Physik und Medizin GmbH · May 2022