510(k) · Cleared
Recalled · Class II · 2013Hemosil Recombiplastin 2G
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 Aug 15, 2007 as substantially equivalent to K043184 (Instrumentation Laboratory CO, 2004) after a 224-day review. Its family tree reaches back 3 generations to 1986. 2 later devices descend from it. It has been recalled once.
- Decided
- Aug 15, 2007
- Review
- 224 days
- Class
- Class II
- Product code
- GJS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K862301 (1986). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK862301 IL System 810, Acl and the Reagent SetsInstrumentation Laboratory CO · 1986
- 2 generations backK012768 Hemosil Recombi PlastinInstrumentation Laboratory CO · 2001
- 1 generation backK043184 Hemosil RecombiplastinInstrumentation Laboratory CO · 2004 · Recalled
- This deviceK070005 Hemosil Recombiplastin 2GInstrumentation Laboratory CO · 2007
- Descendant · cites it directly · 1 of its ownK122584 Hemosil Readiplas TinInstrumentation Laboratory CO · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK213426 HemosIL ReadiPlasTinInstrumentation Laboratory CO · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862301 | IL System 810, Acl and the Reagent Sets | Instrumentation Laboratory CO | 1986 | — |
| −2 | K012768 | Hemosil Recombi Plastin | Instrumentation Laboratory CO | 2001 | — |
| −1 | K043184 | Hemosil Recombiplastin | Instrumentation Laboratory CO | 2004 | 1 |
| 0 (this device) | K070005 | Hemosil Recombiplastin 2G | Instrumentation Laboratory CO | 2007 | — |
| +1 | K122584 | Hemosil Readiplas Tin | Instrumentation Laboratory CO | 2013 | 4 |
| +2 | K213426 | HemosIL ReadiPlasTin | Instrumentation Laboratory CO | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K043184 | Hemosil RecombiplastinSummary page 1…bin Time Test Class II 81GJS Test, Time, Prothrombin 864.7340 Fibrinogen Determination System Class II 81GIS Test, Fibrinogen Predicate Device: K043184 HemoslL RecombiPlasTin Device Description: The RecombiPlasTin 2G reagent is formulated to be insensitive to therapeutic leve… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122584 | Hemosil Readiplas Tin | 2013 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 9, 2013 | Class II | Z-1784-2013 | Nonconforming Material/Component | Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 1 company; a new generation was cleared every 3.3 years on median.
- 5 of the 7 ancestors have a recall of any class.
- Of its descendants, K122584 (Instrumentation Laboratory CO, 2013) has gone furthest, with 1 descendant 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. 2007, this device’s year, is highlighted.
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 and 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 as stated in the FDA summary.
https://510kreport.com/device/K070005 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070005: Hemosil Recombiplastin 2G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070005
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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