510(k) · Cleared
ClearedPotens +
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wada, Inc. · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Dec 8, 2003 as substantially equivalent to K962857 (Organon Teknika Corp., 1997) and 1 other predicate after a 69-day review. Its family tree reaches back 2 generations to 1982.
- Decided
- Dec 8, 2003
- Review
- 69 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K813564 (1982). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K813564 | Coag-a-Mate X2 | General Diagnostics | 1982 | — |
| −1 | K962857 | Coag-a-Mate MTX | Organon Teknika Corp. | 1997 | — |
| 0 (this device) | K033137 | Potens + | Wada, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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? (2)
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 |
|---|---|---|---|
| * | K962857 | Coag-a-Mate MTXSummary page 1…~ally marketed device to which the submitter claims substantial equivalence. Device equivalent to: Organon Tecknika Coag-A-Mate MTX (K962857) for Fibrinogen Organon Tecknika MDA- 180 (K924453) for PT & 1NR (a)(4) A description of the device… | 1997 |
| * | K924453 | Multi-Channel Discrete Analyzer (Mda-180)Summary page 1…l equivalence. Device equivalent to: Organon Tecknika Coag-A-Mate MTX (K962857) for Fibrinogen Organon Tecknika MDA- 180 (K924453) for PT & 1NR (a)(4) A description of the device Device description: Semfi-automated system for in vitro coagulation… | 1992 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 15.0 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K962857.
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?
POTENS+ is an in vitro medical device to determine the coagulation profile of citrated human plasma specimens to be used by a medical professional in a laboratory setting. This profile includes Prothrombin Time (PT) derived Fibrinogen (FBG), and the International Normalization Ratio (INR). Prothrombin Time is used to determine the status of the extrinsic clotting pathway for Clotting Factors I, II, V, VII and X, and to assist in monitoring oral…
Read the full statement (117 words)
POTENS+ is an in vitro medical device to determine the coagulation profile of citrated human plasma specimens to be used by a medical professional in a laboratory setting. This profile includes Prothrombin Time (PT) derived Fibrinogen (FBG), and the International Normalization Ratio (INR).
Prothrombin Time is used to determine the status of the extrinsic clotting pathway for Clotting Factors I, II, V, VII and X, and to assist in monitoring oral anticoagulants.
Fibrinogen is used to diagnose disseminated intravascular coagulation (DIC), as a representation of acute disease - part of the "acute phase response," and it is an independent risk variable in heart attack and stroke prediction.
INR is used to monitor the patients receiving anticoagulation therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033137 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033137: Potens +.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033137
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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