# K971867: Alice 4R System

- Pathway: 510(k) (Traditional)
- Applicant: Healthdyne Technologies, Inc.
- Decided: Aug 13, 1997 after 85 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
105 later devices descend from it; 4 cite it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K971813: EMBLA (1998), 61 descendants of its own
- K040595: ALICE 5 (2004), 40 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

## Indications for use
- The Alice® 4 Sysfem is a polysomnographic system that is intended to record, display, and print EEG and other physiological information to clinicians/physicians. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where adult or infant patients require the documentation of various sleep or other physiological disorders.

Source page: https://510kreport.com/device/K971867
Methodology: https://510kreport.com/methodology