# K211147: ALGO 7i

- Pathway: 510(k) (Traditional)
- Applicant: Path Medical GmbH
- Decided: Oct 14, 2021 after 178 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)
- K030823: Algo 3I Newborn Hearing Screener, Natus Medical, Inc. (2003) Summary page 4.

## Indications for use
The ALGO® 7i Newborn Hearing Screener is a hand-held, portable hearing screener intended to objectively determine the hearing status of a newborn/infant from 34 weeks gestational age to 6 months old. Babies should be well enough for hospital discharge and should be asleep or in a quiet state at the time of screening. Exclusion Criteria The following criteria should be used to exclude an infant from screening with the Natus ALGO hearing screeners: = Infants not between 34 weeks gestational and 6 months of age = Infants on ventilators or in incubators * Infants on CNS (central nervous system) stimulants * Infants receiving ototoxic medications * Infants with compromised skin or jaundice ALGO 7i devices are intended for use by audiologists, ear-nose-throat (ENT) doctors, and other hearing health care professionals, nurses and audiologically trained personnel. Basic training with the device is sufficient for performing screening of patients in good health. It is not intended to be operated by lay users.

Source page: https://510kreport.com/device/K211147
Methodology: https://510kreport.com/methodology