# K233649: ALGO Pro Newborn Hearing Screener (ALGO Pro)

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
- Decided: Mar 8, 2024 after 115 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: 3 generations back to K936039 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073665: Algo 5 Newborn Hearing Screener, Natus Medical, Inc. (2008) Summary page 4.

## Indications for use
The ALGO Pro Newborn Hearing Screener is a mobile, noninvasive instrument used to screen infants for hearing loss. The screener uses Automated Auditory Brainstem Response (AABR®) technology for automated analysis of Auditory Brainstem Response (ABR) signals recorded from the patient. The screener is intended for babies between the ages of 34 weeks (gestation 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/K233649
Methodology: https://510kreport.com/methodology