# K951072: Protime Microcoagulation System

- Pathway: 510(k) (Traditional)
- Applicant: International Technidyne Corp.
- Decided: Oct 27, 1995 after 233 days
- Product code: GKP (Instrument, Coagulation, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Nov 19, 2007 · Not classified · Z-0548-2008: An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages at the point of routine Quality control checks for the Protime Microcoagulation System.
- Dec 6, 2006 · Not classified · Z-0470-2007: Incorrect Test Results-ProTime ITC''s Microcoagulation System: Professional Instrument may report incorrect test results when more than 50 tests are in the memory and the technician uses the AUTO Send

Source page: https://510kreport.com/device/K951072
Methodology: https://510kreport.com/methodology