510(k) · Cleared
Recalled · 2010Thromboscreen Thromboplastin-DS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pacific Hemostasis · GJS Test, Time, Prothrombin
Cleared on Feb 14, 1995 after a 403-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Feb 14, 1995
- Review
- 403 days
- Class
- Class II
- Product code
- GJS
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK940082 Thromboscreen Thromboplastin-DSPacific Hemostasis · 1995
- Descendant · cites it directly · 0 of its ownK060968 Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium…Wortham Laboratories, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK040296 Phosphoplastin RLR2 Diagnostics, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK012410 Infinity Hba Kit, Models 537-a, 537-BSigma Diagnostics, Inc. · 2001
Most influential descendants
Showing 3 of 3 · See all- K060968Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M…Wortham Laboratories, Inc. · 2007 · cites it directly0descendants
- K040296Phosphoplastin RLR2 Diagnostics, Inc. · 2004 · cites it directly0descendants
- K012410Infinity Hba Kit, Models 537-a, 537-BSigma Diagnostics, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940082 | Thromboscreen Thromboplastin-DS | Pacific Hemostasis | 1995 | — |
| +1 | K060968 | Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride… | Wortham Laboratories, Inc. | 2007 | — |
| +1 | K040296 | Phosphoplastin RL | R2 Diagnostics, Inc. | 2004 | — |
| +1 | K012410 | Infinity Hba Kit, Models 537-a, 537-B | Sigma Diagnostics, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GJS? 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 GJS device
- #1 K243543 microINR Systemscore 13.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 6, 2010 | Not classified | Z-1519-2011 | Nonconforming Material/Component | An in vitro diagnostic reagent used in coagulation testing may cause inaccurate clotting times in quality control and patient plasma samples. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060968 (Wortham Laboratories, Inc., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GJS devicesGJS Test, Time, Prothrombin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GJS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GJS
60in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GJS
1in 2022
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · GJS
105in 2025
MAUDE reports naming product code GJS, 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 | 4 | 77 | 5 | 439 |
| 2008 | 1 | — | 3 | 420 |
| 2009 | 0 | — | 4 | 876 |
| 2010 | 4 | 168 | 2 | 2,177 |
| 2011 | 0 | — | 1 | 2,965 |
| 2012 | 1 | — | 1 | 2,198 |
| 2013 | 1 | — | 1 | 2,584 |
| 2014 | 1 | — | 4 (3) | 2,397 |
| 2015 | 0 | — | 0 | 1,260 |
| 2016 | 1 | — | 0 | 864 |
| 2017 | 1 | — | 5 | 532 |
| 2018 | 2 | — | 3 (2) | 1,958 |
| 2019 | 2 | — | 0 | 2,385 |
| 2020 | 1 | — | 2 | 1,390 |
| 2021 | 0 | — | 1 | 1,359 |
| 2022 | 3 | 399 | 1 | 1,210 |
| 2023 | 2 | — | 0 | 809 |
| 2024 | 1 | — | 0 | 177 |
| 2025 | 3 | 60 | 0 | 105 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K940082 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940082: Thromboscreen Thromboplastin-DS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940082
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026