510(k) · Cleared
Recalled · Class II · 2022Hemosil Readiplas Tin
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 Mar 24, 2013 as substantially equivalent to K070005 (Instrumentation Laboratory CO, 2007) after a 212-day review. Its family tree reaches back 4 generations to 1986. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Mar 24, 2013
- Review
- 212 days
- Class
- Class II
- Product code
- GJS
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 4 generations to K862301 (1986). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK862301 IL System 810, Acl and the Reagent SetsInstrumentation Laboratory CO · 1986
- 3 generations backK012768 Hemosil Recombi PlastinInstrumentation Laboratory CO · 2001
- 2 generations backK043184 Hemosil RecombiplastinInstrumentation Laboratory CO · 2004 · Recalled
- 1 generation backK070005 Hemosil Recombiplastin 2GInstrumentation Laboratory CO · 2007 · Recalled
- This deviceK122584 Hemosil Readiplas TinInstrumentation Laboratory CO · 2013
- Descendant · cites it directly · 0 of its ownK213426 HemosIL ReadiPlasTinInstrumentation Laboratory CO · 2022
Most influential descendants
Showing 1 of 1 · See all- K213426HemosIL ReadiPlasTinInstrumentation Laboratory CO · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K862301 | IL System 810, Acl and the Reagent Sets | Instrumentation Laboratory CO | 1986 | — |
| −3 | K012768 | Hemosil Recombi Plastin | Instrumentation Laboratory CO | 2001 | — |
| −2 | K043184 | Hemosil Recombiplastin | Instrumentation Laboratory CO | 2004 | 1 |
| −1 | K070005 | Hemosil Recombiplastin 2G | Instrumentation Laboratory CO | 2007 | 1 |
| 0 (this device) | K122584 | Hemosil Readiplas Tin | Instrumentation Laboratory CO | 2013 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K070005 | Hemosil Recombiplastin 2GSummary page 2…J. Substantial Equivalence Information: 1.Predicatedevice name(s): Hemosl RecombiPlasTin 2G 2. Predicate 510(k) #., K070005 3. Comparison with predicate: Table of similarities: Characteristic jPredicate… | 2007 |
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 |
|---|---|---|---|
| K213426 | HemosIL ReadiPlasTin | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2022 | Class II | Z-1052-2022 | Under Investigation by firm | Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G. |
| Oct 13, 2021 | Class II | Z-0276-2022 | Under Investigation by firm | The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for… |
| Aug 1, 2018 | Class II | Z-0077-2019 | Material/Component Contamination | There is a potential for increased imprecision, out of range quality controls and prolonged sample results. |
| Aug 2, 2017 | Class II | Z-0895-2018 | Under Investigation by firm | Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 1 company; a new generation was cleared every 5.6 years on median.
- 6 of the 8 ancestors have a recall of any class.
- Of its descendants, K213426 (Instrumentation Laboratory CO, 2022) has gone furthest, with 0 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. 2013, 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?
Hemosli. ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP® Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122584 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122584: Hemosil Readiplas Tin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122584
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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