# K990566: Tas Analyzer, Model 1009

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Diagnostics, Inc.
- Decided: May 14, 1999 after 81 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- 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 K933092 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933092: Tas Analyzer, Cardiovascular Diagnostic Services (1993) Summary page 2.

## Indications for use
The TAS analyzer with software version 4.0 is intended to be used with TAS test cards to monitor the hemostatic activity of whole blood and plasma samples. The TAS analyzer is a portable system designed to be used in non-laboratory testing environments by healthcare professionals. TAS test results are reported in quantitative units of measurement.

Source page: https://510kreport.com/device/K990566
Methodology: https://510kreport.com/methodology