# K991087: Hannah Wireless Vital Signs Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Ilife Systems, Inc.
- Decided: Jan 12, 2000 after 287 days
- Product code: FLS (Monitor, Apnea, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.2377
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K822077 (1982). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844327: Edentec Model 2000W Apnea Monitor, Edentec Corp. (1985) Summary page 1.
- K871302: Model 2000W Option H Configuration, Edentec Corp. (1987) Summary page 1.
- K884614: Edentec Model 2000W Option S Cardio-Resp. Process., Edentec Corp. (1989) Summary page 1.
- K901060: Edentec Model 2000W System 700 Monitor, Edentec Corp. (1990) Summary page 1.
- K874148: Monitron System, American Health Products, Inc. (1988) Summary page 1.
- K961972: Model Ami Infant Central Aphea/Heart Rate Monitor, Aequitron Medical, Inc. (1997) Summary page 1.
- K822077: Respiration Monitor Type MR-10, New Dimensions IN Medicine, Inc. (1982) Summary page 1.

## Indications for use
The HANNAH Wireless Vital Signs Monitor is indicated for the continuous monitoring of an infant’s heart rate, respiration rate, and occurrences of central apnea in home, hospital and other environments.

Source page: https://510kreport.com/device/K991087
Methodology: https://510kreport.com/methodology