# K852687: ALGO I

- Pathway: 510(k) (Traditional)
- Applicant: Algotek, Inc.
- Decided: Sep 18, 1985 after 85 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

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

## 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/K852687
Methodology: https://510kreport.com/methodology