# K971650: Rhythmstat XL

- Pathway: 510(k) (Traditional)
- Applicant: Data Critical Corp.
- Decided: Dec 4, 1997 after 212 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- 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 K915624 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945277: Hewlett-Packard Model M1490A Wireless Patient Data Communicator, Hewlett-Packard Co. (1995) Summary page 1.
- K915624: Modified Biolog, Micromedical Industries, Ltd. (1992) Summary page 1.
- (no number) Instromedix LifeSigns Receiving Center: named in the summary without a submission number

## Indications for use
The RhythmStar XL System is indicated for use in the diagnostic evaluation and recording of ECG waveforms from a cardiac event recorder. It is intended to provide remote access to ECG data by transtelephonic transmission from an ambulatory cardiac event monitor to the portable PSION palmtop computer with RhythmSrar XL software.

Source page: https://510kreport.com/device/K971650
Methodology: https://510kreport.com/methodology