# K992598: Tof-Watch SX

- Pathway: 510(k) (Special)
- Applicant: Organon Teknika Corp.
- Decided: Aug 30, 1999 after 27 days
- Product code: KOI (Stimulator, Nerve, Peripheral, Electric)
- Device class: 2
- Regulation: 21 CFR 868.2775
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TOF-Watch: named in the summary without a submission number

## Most influential descendants
- K212434: Neuromuscular Transmission Monitor TOF3D (2022), 1 descendant of its own
- K250887: Neuromuscular Transmission Monitor TOF3D (2510091) (2025), 0 descendants of its own
- K042003: Infinity Trident NMT Pod (2004), 0 descendants of its own

## Indications for use
The TOF-Watch SX device can be used as an objective monitor using accelerometry for measuring the muscle contraction following stimulation of the respective motorneuron, as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring or as a nerve location device.

Source page: https://510kreport.com/device/K992598
Methodology: https://510kreport.com/methodology