510(k) · Cleared
ClearedSta -Calibrator HBPM/LMWH Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostica Stago, Inc. · GGN Plasma, Coagulation Control
Cleared on Apr 9, 2001 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Apr 9, 2001
- Review
- 63 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK010350 Sta -Calibrator HBPM/LMWH KitDiagnostica Stago, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK111822 Sta (R) - Liquid Anti-XA, Multi Hep Calibrator, Quality HNF / Ufh…Diagnostica Stago, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK260214 STA® - Liquid Anti-XaDiagnostica Stago, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK092937 Sta-Hybrid Hep CalibratorDiagnostica Stago, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K111822Sta (R) - Liquid Anti-XA, Multi Hep Calibrator, Quality HNF / Ufh, Quality HBPM / LMWHDiagnostica Stago, Inc. · 2011 · cites it directly1descendant
- K260214STA® - Liquid Anti-XaDiagnostica Stago, Inc. · 2026 · 2 generations on0descendants
- K092937Sta-Hybrid Hep CalibratorDiagnostica Stago, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010350 | Sta -Calibrator HBPM/LMWH Kit | Diagnostica Stago, Inc. | 2001 | — |
| +1 | K111822 | Sta (R) - Liquid Anti-XA, Multi Hep Calibrator, Quality HNF / Ufh, Quality… | Diagnostica Stago, Inc. | 2011 | 3 |
| +2 | K260214 | STA® - Liquid Anti-Xa | Diagnostica Stago, Inc. | 2026 | — |
| +1 | K092937 | Sta-Hybrid Hep Calibrator | Diagnostica Stago, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K111822 (Diagnostica Stago, Inc., 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GGN devicesGGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K010350 · printed Nov 5, 2026
Cite this page
510(k) Report. “K010350: Sta -Calibrator HBPM/LMWH Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K010350
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026