# K936039: Algo-2 Newborn Hearing Screener

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical, Inc.
- Decided: Jan 5, 1995 after 381 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K993177: SABRE (1999), 16 descendants of its own
- 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
- K013137: Algo 3 Newborn Hearing Screener (2001), 5 descendants of its own

## Recalls of this device
- Jun 27, 2005 · Not classified · Z-0985-05: Internal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users.

Source page: https://510kreport.com/device/K936039
Methodology: https://510kreport.com/methodology