510(k) · Cleared
ClearedGeorge King Coumadin Plasma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
George King Bio-Medical, Inc. · GGN Plasma, Coagulation Control
Cleared on Feb 23, 2017 as substantially equivalent to K971219 (Precision Biologicals, Inc., 1997) after a 288-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Feb 23, 2017
- Review
- 288 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971219 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK971219 Cryo Check Inr Validation SetPrecision Biologicals, Inc. · 1997
- This deviceK161316 George King Coumadin PlasmaGeorge King Bio-Medical, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971219 | Cryo Check Inr Validation Set | Precision Biologicals, Inc. | 1997 | — |
| 0 (this device) | K161316 | George King Coumadin Plasma | George King Bio-Medical, Inc. | 2017 | — |
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 GGN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K971219 | Cryo Check Inr Validation SetSummary page 4…ssification Regulation: Plasma, Coagulation E. Substantial Equivalence Information Predicate device name: CryoCheck INR Validation Set Predicate 510(k) number: K971219 Precision BioLogic Inc. 140 Eileen Stubbs Ave, Dartmouth, NS B3B 0A9 Canada Telephone: (902) 468-6482… | 1997 |
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 no recall.
How does its category compare?
All GGN devicesGGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GGN
4in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · GGN
96in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GGN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGN
4in 2018
MAUDE reports naming product code GGN, 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 | 3 | 47 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 37 |
| 2010 | 3 | 23 | 4 | 17 |
| 2011 | 2 | — | 1 | 30 |
| 2012 | 1 | — | 0 | 10 |
| 2013 | 3 | 441 | 3 | 9 |
| 2014 | 2 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 2 | — | 0 | 9 |
| 2017 | 4 | 96 | 0 | 11 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The George King Coumadin® Plasma is an assayed control plasma derived from a single donor on Coumadin® therapy and is intended for in vitro diagnostic use in monitoring the accuracy of the coagulation analyzer and thromboplastin using the clottable prothrombin time/INR on an optical instrument with appropriate commercial reagents. George King Coumadin® Plasma may be used when evaluating a new lot of thromboplastin reagent or new coagulation analyzer.
The intended users of the George King Coumadin® Plasma are trained laboratory personnel working in clinical laboratories.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161316: George King Coumadin Plasma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161316
Report an extraction error
Are you the manufacturer?
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