510(k) · Cleared
ClearedCI-Trol Coagulation Controls II & Iii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade, Baxter Travenol Diagnostics, Inc. · GGN Plasma, Coagulation Control
Cleared on Aug 22, 1977 after a 33-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Aug 22, 1977
- Review
- 33 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK771346 CI-Trol Coagulation Controls II & IiiDade, Baxter Travenol Diagnostics, Inc. · 1977
- Descendant · cites it directly · 1 of its ownK992279 Heparin Control Plasma Level 2Pacific Hemostasis · 1999
- Descendant · cites it directly · 1 of its ownK992278 Heparin Control Plasma Level 1Pacific Hemostasis · 1999
- Descendant · cites it directly · 1 of its ownK984130 Coagulation Control Level 2 (Abnormal)Pacific Hemostasis · 1998
- Descendant · cites it directly · 1 of its ownK984131 Coagulation Control Level 3 (Abnormal)Pacific Hemostasis · 1998
- Descendant · 2 generations on · 0 of its ownK060968 Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium…Wortham Laboratories, Inc. · 2007
Most influential descendants
Showing 5 of 5 · See all- K992279Heparin Control Plasma Level 2Pacific Hemostasis · 1999 · cites it directly1descendant
- K992278Heparin Control Plasma Level 1Pacific Hemostasis · 1999 · cites it directly1descendant
- K984130Coagulation Control Level 2 (Abnormal)Pacific Hemostasis · 1998 · cites it directly1descendant
- K984131Coagulation Control Level 3 (Abnormal)Pacific Hemostasis · 1998 · cites it directly1descendant
- K060968Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M…Wortham Laboratories, Inc. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K771346 | CI-Trol Coagulation Controls II & Iii | Dade, Baxter Travenol Diagnostics, Inc. | 1977 | — |
| +1 | K992279 | Heparin Control Plasma Level 2 | Pacific Hemostasis | 1999 | — |
| +1 | K992278 | Heparin Control Plasma Level 1 | Pacific Hemostasis | 1999 | — |
| +1 | K984130 | Coagulation Control Level 2 (Abnormal) | Pacific Hemostasis | 1998 | — |
| +1 | K984131 | Coagulation Control Level 3 (Abnormal) | Pacific Hemostasis | 1998 | — |
| +2 | K060968 | Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride… | Wortham Laboratories, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2007 | 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? (5)
4 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, K992279 (Pacific Hemostasis, 1999) 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/K771346 · printed Nov 5, 2026
Cite this page
510(k) Report. “K771346: CI-Trol Coagulation Controls II & Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K771346
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026