Cleared Traditional

K955843 - TAS PTONE

K955843 is the FDA 510(k) clearance for TAS PTONE by Cardiovascular Diagnostic Services. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K955843 · Cardiovascular Diagnostic Services · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
83d
Days
Class 2
Risk

K955843 is an FDA 510(k) clearance for the TAS PTONE. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Cardiovascular Diagnostic Services (Raleigh, US). The FDA issued a Cleared decision on March 18, 1996 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardiovascular Diagnostic Services devices

Submission Details

510(k) Number K955843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1995
Decision Date March 18, 1996
Days to Decision 83 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 113d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GJS Test, Time, Prothrombin

All 95
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K955843.
COAGUCHEK PST SYSTEM
K962571 · Boehringer Mannheim Corp. · Apr 1997
PROTIME MICROCOAGULATION SYSTEM
K961835 · International Technidyne Corp. · Mar 1997
STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS
K961938 · Nova Biomedical Corp. · Jun 1996
THROMBOPLASTIN-LI REAGENT
K951820 · Helena Laboratories · Oct 1995
MDA SIMPLASTIN LS
K952608 · Organon Teknika Corp. · Oct 1995
COAGUCHEK SYSTEM
K942884 · Boehringer Mannheim Corp. · May 1995