510(k) · Cleared
ClearedDade Pfa-100 Platelet Function Analyzer and Reagents
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JOZ System, Automated Platelet Aggregation
Cleared on Jul 21, 2006 as substantially equivalent to K970505 (Dade Intl., Inc., 1997) and 1 other predicate after a 147-day review. Its family tree reaches back 2 generations to 1977. 1 later device descends from it.
- Decided
- Jul 21, 2006
- Review
- 147 days
- Class
- Class II
- Product code
- JOZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K771198 (1977). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK771198 Lumi-AggregometerChrono-Log Corp. · 1977
- 1 generation backK970505 Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine…Dade Intl., Inc. · 1997
- This deviceK060489 Dade Pfa-100 Platelet Function Analyzer and ReagentsDade Behring, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK191364 T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL…Fujimori Kogyo, Co., Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K191364T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL…Fujimori Kogyo, Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K771198 | Lumi-Aggregometer | Chrono-Log Corp. | 1977 | — |
| −1 | K970505 | Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test… | Dade Intl., Inc. | 1997 | — |
| 0 (this device) | K060489 | Dade Pfa-100 Platelet Function Analyzer and Reagents | Dade Behring, Inc. | 2006 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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.
Top candidate predicates for a new JOZ device
- #1 K191364 T-TAS 01 Total Thrombus-formation Analysis…score -0.6 · 3 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K970505 | Dade Pfa-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa…Summary page 1…ted platelet aggregation systems, Class II (21 CFR § 864.5700) 3. Identification of the Legally Marketed Device: Dade® PFA-1 00® Platelet Function Analyzer (K970505 and K002885) 4. Device Description: The PFA-100® system provides a tool for clinicians to use in the detection of pla… | 1997 |
| * | K002885 | Dade Pfa-100 Platelet Function Analyzer Model-100, Dade Pfa Collegen/Epinephrine Test…Summary page 1…aggregation systems, Class II (21 CFR § 864.5700) 3. Identification of the Legally Marketed Device: Dade® PFA-1 00® Platelet Function Analyzer (K970505 and K002885) 4. Device Description: The PFA-100® system provides a tool for clinicians to use in the detection of platelet dysfun… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191364 | T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL… | 2020 | 0 |
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 29 years and passes through 3 companies; a new generation was cleared every 20.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K191364 (Fujimori Kogyo, Co., Ltd., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JOZ devicesJOZ System, Automated Platelet Aggregation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
To aid in the detection of platelet dysfunction in citrated human whole blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060489 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060489: Dade Pfa-100 Platelet Function Analyzer and Reagents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060489
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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