# K961817: B Smart Model 1

- Pathway: 510(k) (Traditional)
- Applicant: Koven Technology, Inc.
- Decided: Jul 23, 1997 after 439 days
- Product code: LEL (Device, Sleep Assessment)
- Device class: 2
- Regulation: 21 CFR 882.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K873535 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K873535: Nicolet Expert Sleep/Wake Analysis System, Nicolet Biomedical Instruments (1987) Summary page 1.

## Indications for use
The B SMART Sensory Response Timer is indicated for use in evaluating neurological status during surgery under regional anesthesia by monitoring the capability of the patient to detect and to respond to a timed series of mechanical and auditory stimuli.

Source page: https://510kreport.com/device/K961817
Methodology: https://510kreport.com/methodology