510(k) · Cleared
Recalled · Class II · 2025Pacific Hemostasis Thromboplastin D
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 18, 2000 as substantially equivalent to K901325 (Baxter Healthcare Corp, 1990) after a 77-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Feb 18, 2000
- Review
- 77 days
- Class
- Class II
- Product code
- GJS
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K901325 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK901325 Thromboplastin.C PlusBaxter Healthcare Corp · 1990
- This deviceK994100 Pacific Hemostasis Thromboplastin DPacific Hemostasis · 2000
- Descendant · cites it directly · 0 of its ownK060968 Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium…Wortham Laboratories, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K060968Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M…Wortham Laboratories, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901325 | Thromboplastin.C Plus | Baxter Healthcare Corp | 1990 | — |
| 0 (this device) | K994100 | Pacific Hemostasis Thromboplastin D | Pacific Hemostasis | 2000 | — |
| +1 | K060968 | Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride… | Wortham Laboratories, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 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? (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 |
|---|---|---|---|
| * | K901325 | Thromboplastin.C PlusSummary page 1…s Thromboplastin D Common Name: Thromboplastin D Classification Name: Prothrombin Time Test, per 21 CFR section 864.7750 Comparison Device: Dade Thromboplastin C Plus, K901325 Description of the Device and Intended Use Pacific Hemostasis Thromboplastin D is a lyophilized extract of rabbit brain thrombo… | 1990 |
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 |
|---|---|---|---|
| K060968 | Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M… | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 6, 2025 | Class II | Z-1503-2025 | Employee error | The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. |
| Mar 6, 2025 | Class II | Z-1502-2025 | Employee error | The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 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 | — |
What is it indicated for?
Pacific Hemostasis Thromboplastin D is intended for use for performing the
one-stage Prothrombin Time test (PT) and PT-based factor assays.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994100 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994100: Pacific Hemostasis Thromboplastin D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994100
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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