# K993519: Rapidpoint Accent, Model 2000, Rapidpoint Coag Heparin Titration Test, Rapidpoint Coag Protamine Response Test

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Diagnostics, Inc.
- Decided: Jan 14, 2000 after 88 days
- Product code: JOX (Analyzer, Heparin, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5680
- 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 K911240 (1991). 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)
- K911240: Hepcon HMS with Body Surface Area Calculation, Hemotech, Inc. (1991) Summary page 2.
- (no number) Heparin Dose Response Test: named in the summary without a submission number
- (no number) Heparin Assay Cartridges: named in the summary without a submission number

## Indications for use
The Rapidpoint Accent is an accessory to the Rapidpoint Coag Analyzer. When used in conjunction with the Rapidpoint Coag and the Heparin Management Panel Cards (Heparin Management Test, Heparin Titration Test, and Protamine Response Test) Cards, its intended use is to generate information on heparin management.

Source page: https://510kreport.com/device/K993519
Methodology: https://510kreport.com/methodology