510(k) · Cleared
ClearedPacific Hemostasis Immunodepleted Factor V Deficient Plasma (Thrombosdreen Brand) (100056)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pacific Hemostasis · GJT Plasma, Coagulation Factor Deficient
Cleared on Aug 13, 1997 as substantially equivalent to K912679 (Baxter Healthcare Corp, 1991) after a 30-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Aug 13, 1997
- Review
- 30 days
- Class
- Class II
- Product code
- GJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912679 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK912679 Dade (R) Immunoadsorbed Fact V Def Plasma (Human)Baxter Healthcare Corp · 1991
- This deviceK972627 Pacific Hemostasis Immunodepleted Factor V Deficient Plasma…Pacific Hemostasis · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912679 | Dade (R) Immunoadsorbed Fact V Def Plasma (Human) | Baxter Healthcare Corp | 1991 | — |
| 0 (this device) | K972627 | Pacific Hemostasis Immunodepleted Factor V Deficient Plasma (Thrombosdreen… | Pacific Hemostasis | 1997 | — |
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 GJT? 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 GJT device
- #1 K222831 CRYOcheck Factor VIII Deficient Plasma with VWFscore 6.6 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K912679 | Dade (R) Immunoadsorbed Fact V Def Plasma (Human)Summary page 1…able Classification Name: Plasma, Coagulation Factor Deficient (per 21 CFR section 864.7290) Equivalent Device: Dade® Immunoadsorbed Factor V Deficient Plasma (Human), K912679 Description of Inmunodepleted Factor V Deficient Plasma: Pacific Hemostasis (PH) Immunodepleted Factor V Deficient Plasma is a… | 1991 |
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?
- Its one ancestor has no recall.
How does its category compare?
All GJT devicesGJT Plasma, Coagulation Factor Deficient: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GJT
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GJT
444in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GJT
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GJT
1in 2025
MAUDE reports naming product code GJT, 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 | 0 |
| 2011 | 3 | 444 | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 3 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Pacific Hemostasis Immunodepleted Factor V Deficient Plasma is intended for use in the quantitative determination of Factor V activity in patient plasma. Factor V activity in plasma is assayed by the amount of Prothrombin Time correction produced by the test plasma when mixed with factor deficient plasma. The correction of the unknown is compared to that produced by a reference plasma of known normal activity.
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/K972627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972627: Pacific Hemostasis Immunodepleted Factor V Deficient Plasma (Thrombosdreen Brand) (100056).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972627
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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