510(k) · Cleared
Recalled · 2006Hemosil Recombiplastin
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 Dec 22, 2004 as substantially equivalent to K012768 (Instrumentation Laboratory CO, 2001) and 3 other predicates after a 35-day review. Its family tree reaches back 2 generations to 1986. 3 later devices descend from it. It has been recalled once.
- Decided
- Dec 22, 2004
- Review
- 35 days
- Class
- Class II
- Product code
- GJS
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K862301 (1986). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK862301 IL System 810, Acl and the Reagent SetsInstrumentation Laboratory CO · 1986
- 1 generation backK012768 Hemosil Recombi PlastinInstrumentation Laboratory CO · 2001
- This deviceK043184 Hemosil RecombiplastinInstrumentation Laboratory CO · 2004
- Descendant · cites it directly · 2 of its ownK070005 Hemosil Recombiplastin 2GInstrumentation Laboratory CO · 2007 · Recalled
- Descendant · 2 generations on · 1 of its ownK122584 Hemosil Readiplas TinInstrumentation Laboratory CO · 2013 · Recalled
- Descendant · 3 generations on · 0 of its ownK213426 HemosIL ReadiPlasTinInstrumentation Laboratory CO · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K862301 | IL System 810, Acl and the Reagent Sets | Instrumentation Laboratory CO | 1986 | — |
| −1 | K012768 | Hemosil Recombi Plastin | Instrumentation Laboratory CO | 2001 | — |
| 0 (this device) | K043184 | Hemosil Recombiplastin | Instrumentation Laboratory CO | 2004 | — |
| +1 | K070005 | Hemosil Recombiplastin 2G | Instrumentation Laboratory CO | 2007 | 1 |
| +2 | K122584 | Hemosil Readiplas Tin | Instrumentation Laboratory CO | 2013 | 4 |
| +3 | 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 |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K012768 | Hemosil Recombi PlastinSummary page 1…n Time Test Class 1I 81GJS Test, Time, Prothrombin 864.7340 Fibrinogen Determination System Class II 81GIS Test, Fibrinogen Legally Marketed Device: K012768 HemoslL RecombiPlasTin Device Description: HeemosIL RecombiPlasTin is a high sensitivity thromboplastin reagent based on reco… | 2001 |
| * | K951891 | Acl Futura Coagulation SystemSummary page 1…racteristics of the Device Compared to Predicate Device: The performance of HemosIL RecombiPlasTin with optimized PT and fibrinogen parameter settings on the ACL Futura (K951891) and ACL Advance (K002400) is substantially equivalent to the performance of the current legally marketed device on the ACL TOP (… | 1995 |
| * | K002400 | Modification of Acl AdvanceSummary page 1…Compared to Predicate Device: The performance of HemosIL RecombiPlasTin with optimized PT and fibrinogen parameter settings on the ACL Futura (K951891) and ACL Advance (K002400) is substantially equivalent to the performance of the current legally marketed device on the ACL TOP (K033414). Section 3… | 2000 |
| * | K033414 | Acl Top Model, TopSummary page 1…eter settings on the ACL Futura (K951891) and ACL Advance (K002400) is substantially equivalent to the performance of the current legally marketed device on the ACL TOP (K033414). Section 3 Special 5 10(k): HemoslL RecombiPlasTin Page 1 of 2… | 2004 |
| † | K931721 | IL Test Fibrinogen-C | 1993 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070005 | Hemosil Recombiplastin 2G | 2007 | 2 |
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-1246-06 | 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?
- The line of descent spans 18 years and passes through 1 company; a new generation was cleared every 15.0 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K070005 (Instrumentation Laboratory CO, 2007) has gone furthest, with 2 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?
HemoslL RecombiPlasTin is 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 as stated in the FDA summary.
https://510kreport.com/device/K043184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043184: Hemosil Recombiplastin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043184
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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