# K922106: ALICE

- Pathway: 510(k) (Traditional)
- Applicant: Healthdyne, Inc.
- Decided: Jul 6, 1994 after 792 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- 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.
62 later devices descend from it; 1 cites it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K971813: EMBLA (1998), 61 descendants of its own
- K080427: Watch-Pat Model 100S-2 (2008), 25 descendants of its own
- K081982: Watch-Pat 200S-2 (WP200S-2) (2008), 24 descendants of its own
- K102567: Watch-Pat 200S-3 (WP200S-3) (2011), 23 descendants of its own
- K070375: Earlysense ES-16 System (2007), 23 descendants of its own

## Recalls of this device
- Oct 15, 2007 · Not classified · Z-1090-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.

Source page: https://510kreport.com/device/K922106
Methodology: https://510kreport.com/methodology