510(k) · Cleared
ClearedT-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujimori Kogyo, Co., Ltd. · JOZ System, Automated Platelet Aggregation
Cleared on Feb 14, 2020 as substantially equivalent to K060489 (Dade Behring, Inc., 2006) after a 268-day review. Its family tree reaches back 3 generations to 1977.
- Decided
- Feb 14, 2020
- Review
- 268 days
- Class
- Class II
- Product code
- JOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K771198 (1977). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK771198 Lumi-AggregometerChrono-Log Corp. · 1977
- 2 generations backK970505 Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine…Dade Intl., Inc. · 1997
- 1 generation backK060489 Dade Pfa-100 Platelet Function Analyzer and ReagentsDade Behring, Inc. · 2006
- This deviceK191364 T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL…Fujimori Kogyo, Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K771198 | Lumi-Aggregometer | Chrono-Log Corp. | 1977 | — |
| −2 | K970505 | Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test… | Dade Intl., Inc. | 1997 | — |
| −1 | K060489 | Dade Pfa-100 Platelet Function Analyzer and Reagents | Dade Behring, Inc. | 2006 | — |
| 0 (this device) | K191364 | T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for… | Fujimori Kogyo, Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JOZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060489 | Dade Pfa-100 Platelet Function Analyzer and ReagentsSummary page 4…el: Hematology Predicate Method: Product Name: Dade Behring (now Siemens) PFA-100 510(k) Document Number: K060489 Device Description: The T-TAS 01 system is an in vitro diagnostic device that is comprised of tabletop instrument controlled b… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 43 years and passes through 4 companies; a new generation was cleared every 13.6 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All JOZ devicesJOZ System, Automated Platelet Aggregation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · JOZ
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · JOZ
Too few JOZ 510(k)s in any year since 2007 to give a median.
Recalls per year · JOZ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOZ
3in 2025
MAUDE reports naming product code JOZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 1 | — | 0 | 9 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 1 |
| 2025 | 0 | — | 1 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The T-TAS 01 Instrument is intended for use with T-TAS reagent chips in the clinical laboratory. The T-TAS 01 PL chip is intended for use in the clinical laboratory for the analysis of the platelet thrombus formation process (primary hemostatic function) in patients age 21 and older with a history of conditions associated with impaired primary hemostatic function or use of antiplatelet therapy. The test uses BAPA-anticoagulated whole blood specimens to…
Read the full statement (186 words)
The T-TAS 01 Instrument is intended for use with T-TAS reagent chips in the clinical laboratory.
The T-TAS 01 PL chip is intended for use in the clinical laboratory for the analysis of the platelet thrombus formation process (primary hemostatic function) in patients age 21 and older with a history of conditions associated with impaired primary hemostatic function or use of antiplatelet therapy. The test uses BAPA-anticoagulated whole blood specimens to measure platelet adhesion to a thrombogenic collagen-coated surface and aggregation, which causes an increase in flow pressure inside the PL chip. The test measures primary hemostatic function as the area under the pressure-time curve (AUC), with AUC < 260 suggesting abnormal primary hemostatic function. Additional testing may be necessary to identify the cause(s) of abnormal primary hemostatic function. The test has been evaluated in patients taking antiplatelet therapy, in patients with von Willebrand disease, and in patients with Glanzmann’s thrombasthenia. Other primary hemostasis disorders have not been evaluated.
The BAPA tube for T-TAS 01 is intended to be used for the collection, transport, and storage of blood specimens for use with the T-TAS 01 system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191364: T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191364
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026