# K993177: SABRE

- Pathway: 510(k) (Traditional)
- Applicant: Sle Limited
- Decided: Nov 16, 1999 after 85 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: 1 generation back to K925648 (1993). 3 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936039: Algo-2 Newborn Hearing Screener, Natus Medical, Inc. (1995). Our OCR of the scanned summary read K936093, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Algo-2 Newborn Hearing Screener”.
- K952080: Clarity System II, Sonamed Corp. (1995) Summary page 1.
- K925648: Smart-Screener (Auditory), Intelligent Hearing Systems (1993) Summary page 1.

## Most influential descendants
- K013977: Echo-Screen T, TA, TD, Tda, TC (2002), 14 descendants of its own
- K122067: Type 1077 Accuscreen (2012), 9 descendants of its own
- K061744: Cochlea-Scan / Cochlea-Scan Plus (2006), 5 descendants of its own
- K133012: Sentiero (2014), 4 descendants of its own
- K132957: Madsen Accuscreen Type 1077 (2014), 3 descendants of its own

## Indications for use
The SABRE Auditory Brainstem Response Screener ig a device that produces a sound stimulus for use in evoked responsc mcasurcments. It is intended to be used by trained protessiocnals in ‘the evaluation of hearing function.

Source page: https://510kreport.com/device/K993177
Methodology: https://510kreport.com/methodology