510(k) · Cleared
ClearedHemosil Recombi Plastin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · GJS Test, Time, Prothrombin
Cleared on Sep 18, 2001 as substantially equivalent to K925604 (Ortho Diagnostic Systems, Inc., 1993) and 1 other predicate after a 32-day review. Its family tree reaches back 1 generation to 1986. 4 later devices descend from it.
- Decided
- Sep 18, 2001
- Review
- 32 days
- Class
- Class II
- Product code
- GJS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K862301 (1986). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK862301 IL System 810, Acl and the Reagent SetsInstrumentation Laboratory CO · 1986
- This deviceK012768 Hemosil Recombi PlastinInstrumentation Laboratory CO · 2001
- Descendant · cites it directly · 3 of its ownK043184 Hemosil RecombiplastinInstrumentation Laboratory CO · 2004 · Recalled
- Descendant · 2 generations on · 2 of its ownK070005 Hemosil Recombiplastin 2GInstrumentation Laboratory CO · 2007 · Recalled
- Descendant · 3 generations on · 1 of its ownK122584 Hemosil Readiplas TinInstrumentation Laboratory CO · 2013 · Recalled
- Descendant · 4 generations on · 0 of its ownK213426 HemosIL ReadiPlasTinInstrumentation Laboratory CO · 2022
Most influential descendants
Showing 4 of 4 · See all- K043184Hemosil RecombiplastinInstrumentation Laboratory CO · 2004 · cites it directly3descendants
- K070005Hemosil Recombiplastin 2GInstrumentation Laboratory CO · 2007 · 2 generations on2descendants
- K122584Hemosil Readiplas TinInstrumentation Laboratory CO · 2013 · 3 generations on1descendant
- K213426HemosIL ReadiPlasTinInstrumentation Laboratory CO · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862301 | IL System 810, Acl and the Reagent Sets | Instrumentation Laboratory CO | 1986 | — |
| 0 (this device) | K012768 | Hemosil Recombi Plastin | Instrumentation Laboratory CO | 2001 | — |
| +1 | K043184 | Hemosil Recombiplastin | Instrumentation Laboratory CO | 2004 | 1 |
| +2 | K070005 | Hemosil Recombiplastin 2G | Instrumentation Laboratory CO | 2007 | 1 |
| +3 | K122584 | Hemosil Readiplas Tin | Instrumentation Laboratory CO | 2013 | 4 |
| +4 | K213426 | HemosIL ReadiPlasTin | Instrumentation Laboratory CO | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K925604 | Ortho (TM) Recombiplastin W/Ortho DiluentSummary page 1…rombin Time Test Class II 81GJS Test, Time, Prothrombin 864.7340 Fibrinogen Determination System Class II 81GIS Test, Fibrinogen Identification of Predicate Device(s): K925604 Hemoliance® RecombiPlasTin (PT Claims for IL Coagulation and ELECTRA Systems) K862301 IL Test™ PT-Fibrinogen (Fibrinogen Claims… | 1993 |
| * | K862301 | IL System 810, Acl and the Reagent SetsSummary page 1…on System Class II 81GIS Test, Fibrinogen Identification of Predicate Device(s): K925604 Hemoliance® RecombiPlasTin (PT Claims for IL Coagulation and ELECTRA Systems) K862301 IL Test™ PT-Fibrinogen (Fibrinogen Claims for IL Coagulation Systems Only) Description of the Device/Intended Use(s): A high sen… | 1986 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043184 | Hemosil Recombiplastin | 2004 | 3 |
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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K043184 (Instrumentation Laboratory CO, 2004) has gone furthest, with 3 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?
A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in vitro diagnostic determination in human citrated plasma of:
- Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems
- Fibrinogen on IL Coagulation Systems only
The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
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/K012768 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012768: Hemosil Recombi Plastin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012768
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026