510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993519Substantially Equivalent

Rapidpoint Accent, Model 2000, Rapidpoint Coag Heparin Titration Test, Rapidpoint Coag Protamine Response Test

Cardiovascular Diagnostics, Inc., Raleigh NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993519 is the FDA 510(k) clearance record for RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST, a class II device, cleared for Cardiovascular Diagnostics, Inc. on under FDA product code JOX (Analyzer, Heparin, Automated). FDA records list 13 510(k) clearances for Cardiovascular Diagnostics, Inc., from to . As of , FDA records show no recalls naming K993519.

Clearance record

Decision date
Received
(88 days to decision)
Product code
JOX Analyzer, Heparin, Automated
Regulation
21 CFR 864.5680
Device class
Class II
Review panel
Hematology
Applicant
Cardiovascular Diagnostics, Inc. 5301 Departure Dr., Raleigh NC
510(k) summary
Summary
Third party review
No

Clearances, product code JOX

Trailing 12 months

FDA records hold no clearances under product code JOX in the trailing twelve months.

FDA records show no clearances under product code JOX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JOX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260