510(k) · Cleared
Recalled · 2006Ortho (TM) Recombiplastin W/Ortho Diluent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Diagnostic Systems, Inc. · GJS Test, Time, Prothrombin
Cleared on Mar 12, 1993 after a 127-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled once.
- Decided
- Mar 12, 1993
- Review
- 127 days
- Class
- Class II
- Product code
- GJS
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK925604 Ortho (TM) Recombiplastin W/Ortho DiluentOrtho Diagnostic Systems, Inc. · 1993
- Descendant · cites it directly · 4 of its ownK012768 Hemosil Recombi PlastinInstrumentation Laboratory CO · 2001
- Descendant · 2 generations on · 3 of its ownK043184 Hemosil RecombiplastinInstrumentation Laboratory CO · 2004 · Recalled
- Descendant · 3 generations on · 2 of its ownK070005 Hemosil Recombiplastin 2GInstrumentation Laboratory CO · 2007 · Recalled
- Descendant · 4 generations on · 1 of its ownK122584 Hemosil Readiplas TinInstrumentation Laboratory CO · 2013 · Recalled
- Descendant · 5 generations on · 0 of its ownK213426 HemosIL ReadiPlasTinInstrumentation Laboratory CO · 2022
Most influential descendants
Showing 5 of 5 · See all- K012768Hemosil Recombi PlastinInstrumentation Laboratory CO · 2001 · cites it directly4descendants
- K043184Hemosil RecombiplastinInstrumentation Laboratory CO · 2004 · 2 generations on3descendants
- K070005Hemosil Recombiplastin 2GInstrumentation Laboratory CO · 2007 · 3 generations on2descendants
- K122584Hemosil Readiplas TinInstrumentation Laboratory CO · 2013 · 4 generations on1descendant
- K213426HemosIL ReadiPlasTinInstrumentation Laboratory CO · 2022 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925604 | Ortho (TM) Recombiplastin W/Ortho Diluent | Ortho Diagnostic Systems, Inc. | 1993 | — |
| +1 | K012768 | Hemosil Recombi Plastin | Instrumentation Laboratory CO | 2001 | — |
| +2 | K043184 | Hemosil Recombiplastin | Instrumentation Laboratory CO | 2004 | 1 |
| +3 | K070005 | Hemosil Recombiplastin 2G | Instrumentation Laboratory CO | 2007 | 1 |
| +4 | K122584 | Hemosil Readiplas Tin | Instrumentation Laboratory CO | 2013 | 4 |
| +5 | K213426 | HemosIL ReadiPlasTin | Instrumentation Laboratory CO | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2022 | 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? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012768 | Hemosil Recombi Plastin | 2001 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 7, 2006 | Not classified | Z-1247-06 | Other | Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012768 (Instrumentation Laboratory CO, 2001) has gone furthest, with 4 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/K925604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925604: Ortho (TM) Recombiplastin W/Ortho Diluent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925604
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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