510(k) · Cleared
ClearedPhosphoplastin RL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R2 Diagnostics, Inc. · GJS Test, Time, Prothrombin
Cleared on May 24, 2004 as substantially equivalent to K940082 (Pacific Hemostasis, 1995) after a 105-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- May 24, 2004
- Review
- 105 days
- Class
- Class II
- Product code
- GJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940082 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK940082 Thromboscreen Thromboplastin-DSPacific Hemostasis · 1995 · Recalled
- This deviceK040296 Phosphoplastin RLR2 Diagnostics, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940082 | Thromboscreen Thromboplastin-DS | Pacific Hemostasis | 1995 | 1 |
| 0 (this device) | K040296 | Phosphoplastin RL | R2 Diagnostics, Inc. | 2004 | — |
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 |
|---|---|---|---|
| * | K940082 | Thromboscreen Thromboplastin-DSSummary page 1…Test, Time, Prothrombin (per 21 CFR section 864.7750) Comparison Device: Phosphoplastin R, K940082 Description of the Device and Intended Use Phosphoplastin RL PT reagent is a liquid, ready-to-use reagent containing throm… | 1995 |
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?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K940082.
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?
The Phosphoplastin RL Prothrombin Time reagent is a liquid PT reagent containing thromboplastin derived from rabbit brain and calcium ions for use in the determination of Prothrombin Time (PT) and related coagulation procedures. The PT test is a one-stage quantitative test performed on plasma samples in the general patient population. The PT test is used in routine patient screening for disorders in the extrinsic pathway of coagulation and for the monitoring of patients undergoing Oral Anti-Coagulant (OAC) therapy. Phosphoplastin RL should only be used in an appropriate clinical laboratory by qualified laboratory personnel and is provided ready-to-use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040296: Phosphoplastin RL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040296
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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