510(k) · Cleared
ClearedCoagulation Control Level 3 (Abnormal)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pacific Hemostasis · GGC Control, Plasma, Abnormal
Cleared on Dec 1, 1998 as substantially equivalent to K771346 (Dade, Baxter Travenol Diagnostics, Inc., 1977) after a 13-day review. Its family tree reaches back 1 generation to 1977. 1 later device descends from it.
- Decided
- Dec 1, 1998
- Review
- 13 days
- Class
- Class II
- Product code
- GGC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K771346 (1977). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK771346 CI-Trol Coagulation Controls II & IiiDade, Baxter Travenol Diagnostics, Inc. · 1977
- This deviceK984131 Coagulation Control Level 3 (Abnormal)Pacific Hemostasis · 1998
- Descendant · cites it directly · 0 of its ownK060968 Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium…Wortham Laboratories, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K060968Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M…Wortham Laboratories, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771346 | CI-Trol Coagulation Controls II & Iii | Dade, Baxter Travenol Diagnostics, Inc. | 1977 | — |
| 0 (this device) | K984131 | Coagulation Control Level 3 (Abnormal) | Pacific Hemostasis | 1998 | — |
| +1 | 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 |
|---|---|---|
| 2007 | 1 | 0 |
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 GGC? 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 |
|---|---|---|---|
| * | K771346 | CI-Trol Coagulation Controls II & IiiSummary page 1…normal Coagulation Control Classification Nérfie: Plasma, Coagulation Control (per 21 CFR section 864.5425) Equivalent Device: Dade Ci-Trol Coagulation Control Level III, K771346 Description of Coagulation Control Level 3 (Abnormal) Pacific Hemostasis Coagulation Control Level 3 (Abnormal) is a lyophilize… | 1977 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060968 | Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M… | 2007 | 0 |
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?
How does its category compare?
All GGC devicesGGC Control, Plasma, Abnormal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGC
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · GGC
Too few GGC 510(k)s in any year since 2007 to give a median.
Recalls per year · GGC
No recall names GGC since 2007.
Adverse event reports per year · GGC
1in 2021
MAUDE reports naming product code GGC, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Pacific Hemostasis Coagulation Control, Abnormal, Level 3, is intended for use as a control to monitor the performance of two routine coagulation assays: Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT), in the markedly abnormal range.
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/K984131 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984131: Coagulation Control Level 3 (Abnormal).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984131
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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