# K030823: Algo 3I Newborn Hearing Screener

- Pathway: 510(k) (Special)
- Applicant: Natus Medical, Inc.
- Decided: Apr 9, 2003 after 26 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
Longest line of descent: 2 generations back to K936039 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K013137: Algo 3 Newborn Hearing Screener, Natus Medical, Inc. (2001)

## Most influential descendants
- K211147: ALGO 7i (2021), 0 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.

## Indications for use
The ALGO® 3i Newborn Hearing Screener is a portable, noninvasive instrument used to screen infants for hearing loss. The Screener uses AABR® technology. The screener is intended for babies between the ages of 34 weeks (gestational age) and 6 months. Babies should be well enough to be ready for discharge from the hospital, and should be asleep or in a quiet state at the time of screening.

Source page: https://510kreport.com/device/K030823
Methodology: https://510kreport.com/methodology