# K011842: Sabre Compac

- Pathway: 510(k) (Traditional)
- Applicant: Sle Limited
- Decided: Jan 8, 2002 after 210 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K925648 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993177: SABRE, Sle Limited (1999) Summary page 1.

## Indications for use
The SABRe Compac Auditory Brainstem Response Screener is a device that produces a sound stimulus for use in evoked response measurements. It is intended to be used by trained professionals in the determination of hearing disorders.

Source page: https://510kreport.com/device/K011842
Methodology: https://510kreport.com/methodology