510(k) · Cleared
ClearedModification to Standard Human Plasma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Jan 16, 2003 as substantially equivalent to K924393 (Behring Diagnostics, Inc., 1992) after a 118-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Jan 16, 2003
- Review
- 118 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924393 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK924393 Standard Human PlasmaBehring Diagnostics, Inc. · 1992
- This deviceK023141 Modification to Standard Human PlasmaDade Behring, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK091284 Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and…Affinity Biologicals, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K091284Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control PlasmaAffinity Biologicals, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924393 | Standard Human Plasma | Behring Diagnostics, Inc. | 1992 | — |
| 0 (this device) | K023141 | Modification to Standard Human Plasma | Dade Behring, Inc. | 2003 | — |
| +1 | K091284 | Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal… | Affinity Biologicals, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 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? (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 |
|---|---|---|---|
| * | K924393 | Standard Human PlasmaSummary page 1…an Plasma / Multipurpose system for in vitro coagulation studies (864.5425) 3. Identification of the Legally Marketed Device: Standard Human Plasma (K924393) 4. Device Description: Standard Human Plasma is a lyophilized calibrator prepared from pooled citrated huma… | 1992 |
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 |
|---|---|---|---|
| K091284 | Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control Plasma | 2009 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K091284 (Affinity Biologicals, Inc., 2009) has gone furthest, with 0 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 | — |
What is it indicated for?
For the calibration of the following tests:
1. Prothrombin time (PT)
2. Fibrinogen
3. Coagulation factors II, V, VII, VIII, wWf, IX, X, XI, XI1 and XIII*
4. Inhibitors: Antithrombin Ill, Protein C, Protein S , a2-antiplasmin, C1-inhibitor*
5. Total complement activity*
6. Plasminogen
* Not available in the U.S.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023141: Modification to Standard Human Plasma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023141
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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