510(k) · Cleared
ClearedIL Test 84673-30 Chromogenics Control Plasma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Nov 25, 1986 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Nov 25, 1986
- Review
- 27 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK864271 IL Test 84673-30 Chromogenics Control PlasmaInstrumentation Laboratory CO · 1986
- Descendant · cites it directly · 3 of its ownK021024 Hemosil High Abnormal Control AssayedInstrumentation Laboratory CO · 2002 · Recalled
- Descendant · cites it directly · 2 of its ownK021022 Hemosil Low Abnormal Controlled (Assayed); Hemosil Low Abnormal…Instrumentation Laboratory CO · 2002 · Recalled
- Descendant · 2 generations on · 1 of its ownK082859 Hemosil Routine Control Level 1, Level 2, Level 3 UnassayedInstrumentation Laboratory CO · 2008
- Descendant · 2 generations on · 0 of its ownK173202 CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator…Sekisui Medical Co., Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK110432 Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen AbnAffinity Biologicals, Inc. · 2011
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K021024Hemosil High Abnormal Control AssayedInstrumentation Laboratory CO · 2002 · cites it directly3descendants
- K021022Hemosil Low Abnormal Controlled (Assayed); Hemosil Low Abnormal Control 2 (Unassayed)Instrumentation Laboratory CO · 2002 · cites it directly2descendants
- K082859Hemosil Routine Control Level 1, Level 2, Level 3 UnassayedInstrumentation Laboratory CO · 2008 · 2 generations on1descendant
- K173202CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control SetSekisui Medical Co., Ltd. · 2018 · 2 generations on0descendants
- K110432Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen AbnAffinity Biologicals, Inc. · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K864271 | IL Test 84673-30 Chromogenics Control Plasma | Instrumentation Laboratory CO | 1986 | — |
| +1 | K021024 | Hemosil High Abnormal Control Assayed | Instrumentation Laboratory CO | 2002 | 3 |
| +1 | K021022 | Hemosil Low Abnormal Controlled (Assayed); Hemosil Low Abnormal Control 2… | Instrumentation Laboratory CO | 2002 | 3 |
| +2 | K082859 | Hemosil Routine Control Level 1, Level 2, Level 3 Unassayed | Instrumentation Laboratory CO | 2008 | — |
| +2 | K173202 | CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia… | Sekisui Medical Co., Ltd. | 2018 | — |
| +3 | K110432 | Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen Abn | Affinity Biologicals, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2018 | 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 JPA? 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 JPA device
- #1 K243858 TEG 6s Hemostasis System Citrated: K, KH, RT…score 12.0 · 2 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? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K021024 (Instrumentation Laboratory CO, 2002) has gone furthest, with 3 descendants of its own.
How does its category compare?
All JPA devicesJPA System, Multipurpose For In Vitro Coagulation Studies: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JPA
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JPA
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPA
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPA
11in 2025
MAUDE reports naming product code JPA, 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 | 1 | — | 1 | 1,744 |
| 2008 | 2 | — | 0 | 918 |
| 2009 | 6 | 91 | 0 | 1,363 |
| 2010 | 1 | — | 6 | 727 |
| 2011 | 1 | — | 4 | 161 |
| 2012 | 0 | — | 1 | 52 |
| 2013 | 1 | — | 0 | 43 |
| 2014 | 0 | — | 0 | 48 |
| 2015 | 2 | — | 0 | 45 |
| 2016 | 6 | 114 | 3 | 6 |
| 2017 | 4 | 117 | 0 | 15 |
| 2018 | 1 | — | 0 | 39 |
| 2019 | 3 | 175 | 0 | 27 |
| 2020 | 0 | — | 1 | 18 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 3 | 506 | 0 | 11 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 3 | 30 | 0 | 11 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K864271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K864271: IL Test 84673-30 Chromogenics Control Plasma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K864271
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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