510(k) · Cleared
ClearedPhospholin ES and Calcium Chloride
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R2 Diagnostics, Inc. · GGW Test, Time, Partial Thromboplastin
Cleared on Feb 4, 2004 as substantially equivalent to K863594 (American Dade, 1986) after a 93-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Feb 4, 2004
- Review
- 93 days
- Class
- Class II
- Product code
- GGW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K863594 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK863594 Actin FSL Activated PTT ReagentAmerican Dade · 1986 · Recalled
- This deviceK033471 Phospholin ES and Calcium ChlorideR2 Diagnostics, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863594 | Actin FSL Activated PTT Reagent | American Dade | 1986 | 2 |
| 0 (this device) | K033471 | Phospholin ES and Calcium Chloride | 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 GGW? 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 GGW device
- #1 K260551 HemosIL Factor V Leiden (APC Resistance V)score 11.3 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K863594 | Actin FSL Activated PTT ReagentSummary page 1…est, Time, Partial Thromboplastin (per 21 CFR section 864.7925) Comparison Device: Dade Actin FSL, K863594 Stago Calcium Chloride Description of the Device and Intended Use R2 Diagnostics Ph… | 1986 |
| * | — | Stago Calcium Chloride Named without a submission number |
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.
How does its category compare?
All GGW devicesGGW Test, Time, Partial Thromboplastin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGW
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · GGW
Too few GGW 510(k)s in any year since 2007 to give a median.
Recalls per year · GGW
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGW
11in 2025
MAUDE reports naming product code GGW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 18 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Phospholin ES Activated Partial Thromboplastin Time reagent is a liquid activated reagent with phospholipids derived from soybean lecithin for use in the determination of Activated Partial Thromboplastin Time (APTT) and related coagulation procedures. Phospholin ES is to be used as an APTT reagent (qualitative assay) on patient plasma for the routine screening in the general patient population for deficiencies involving the intrinsic pathway of coagulation. Phospholin ES is sensitive to lupus-like inhibitors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033471 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033471: Phospholin ES and Calcium Chloride.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033471
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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