# K993788: R.Test Evolution

- Pathway: 510(k) (Traditional)
- Applicant: Novacor Div.
- Decided: Aug 4, 2000 after 269 days
- Product code: MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm)
- Device class: 2
- Regulation: 21 CFR 870.2800
- 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 K844391 (1985). 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)
- K880626: King of Hearts, Instromedix, Inc. (1988). Our OCR of the scanned summary read K880620, FDA’s number for Emit Thyroxine Assay (Syva Co.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “King of Hearts Recorder”.
- K844391: Novacor's R-Test 60 & R-Test 160 Ecg Recorders, Ams Medical, Inc. (1985) Summary page 1.

## Indications for use
The R-Test Evolution is a miniature ambulatory ECG Event Recorder that is connected to the patient. This version (automatic mode) is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient’s continuous heart rate trend, and is capable of up to eight day ambulatory recording.

Source page: https://510kreport.com/device/K993788
Methodology: https://510kreport.com/methodology