# K013137: Algo 3 Newborn Hearing Screener

- Pathway: 510(k) (Special)
- Applicant: Natus Medical, Inc.
- Decided: Oct 16, 2001 after 27 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: 1 generation back to K936039 (1995). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 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) Summary page 1.

## Most influential descendants
- K073665: Algo 5 Newborn Hearing Screener (2008), 1 descendant of its own
- K030823: Algo 3I Newborn Hearing Screener (2003), 1 descendant of its own
- K233649: ALGO Pro Newborn Hearing Screener (ALGO Pro) (2024), 0 descendants of its own
- K211147: ALGO 7i (2021), 0 descendants of its own
- K111555: Circumaural Adhesive Replacement (2011), 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® 3 Newborn Hearing Screener is a mobile, 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. The screener is simple to operate. It does not require special technical skills or interpretation of results. Basic training with the equipment is sufficient to learn how to screen infants who are in good health and about to be discharged from the hospital. A typical screening process can be completed in 15 minutes or less. Sites appropriate for screening include the well-baby nursery, NICU, mother’s bedside, audiology suite, outpatient clinic, or doctor’s office.

Source page: https://510kreport.com/device/K013137
Methodology: https://510kreport.com/methodology