510(k) · Cleared
ClearedFisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus Kaolin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher Diagnostics · GKP Instrument, Coagulation, Automated
Cleared on Dec 9, 2002 as substantially equivalent to K884863 (Medical Laboratory Automation Systems, Inc., 1989) and 2 other predicates after a 63-day review. Its family tree reaches back 1 generation to 1978. 1 later device descends from it.
- Decided
- Dec 9, 2002
- Review
- 63 days
- Class
- Class II
- Product code
- GKP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K781880 (1978). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK781880 Assay Kit, Thrombo-ScreenPacific Hemostasis · 1978
- This deviceK023362 Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen…Fisher Diagnostics · 2002
- 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 | K781880 | Assay Kit, Thrombo-Screen | Pacific Hemostasis | 1978 | — |
| 0 (this device) | K023362 | Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent… | Fisher Diagnostics | 2002 | — |
| +1 | K060968 | Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride… | Wortham Laboratories, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
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 GKP? 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 GKP device
- #1 K242127 ACL TOP Family 50 Series (ACL TOP 750; ACL TOP…score 9.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K884863 | Electra 900C Automatic Coagulation TimerSummary page 1…Fibrinogen Test 21 CFR 864.7340 Equivalent Devices: MLA 9OOC (K884863) MLA 1600C (K93 1206) Fibrinogen Reag… | 1989 |
| * | K931206 | Electra 1600C Automatic Coagulation TimerSummary page 1…21 CFR 864.7340 Equivalent Devices: MLA 9OOC (K884863) MLA 1600C (K93 1206) Fibrinogen Reagent (K78 1880) Description of the Devices The ThromboScreen@1000… | 1993 |
| * | K781880 | Assay Kit, Thrombo-ScreenSummary page 1…MLA 9OOC (K884863) MLA 1600C (K93 1206) Fibrinogen Reagent (K78 1880) Description of the Devices The ThromboScreen@1000 (TS 1000) is a photo-optical instrument used for the performance of in-vitro… | 1978 |
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GKP devicesGKP Instrument, Coagulation, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GKP
Too few GKP 510(k)s in any year since 2007 to give a median.
Recalls per year · GKP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKP
5in 2024
MAUDE reports naming product code GKP, 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 | 1 | — | 3 | 3 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 1 | — | 0 | 190 |
| 2010 | 0 | — | 4 | 74 |
| 2011 | 0 | — | 0 | 45 |
| 2012 | 0 | — | 0 | 35 |
| 2013 | 0 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 24 |
| 2016 | 1 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 38 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 17 |
| 2022 | 0 | — | 1 | 4 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Pacific Hemostasis® Fibrinogen Reagent plus Kaolin is intended to be used on the Fisher Diagnostics ThromboScreen® 1000 Coagulation Instrument for the quantitative determination of fibrinogen in plasma.
The Fisher Diagnostics ThromboScreen® 1000 is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing of citrated plasma specimens in the clinical laboratory. Coagulation testing capabilities of the device include routine clotting tests such as Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and Fibrinogen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023362: Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus Kaolin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023362
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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