510(k) · Cleared
ClearedHeparin Control Plasma Level 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pacific Hemostasis · GGN Plasma, Coagulation Control
Cleared on Aug 26, 1999 as substantially equivalent to K771346 (Dade, Baxter Travenol Diagnostics, Inc., 1977) after a 50-day review. Its family tree reaches back 1 generation to 1977. 1 later device descends from it.
- Decided
- Aug 26, 1999
- Review
- 50 days
- Class
- Class II
- Product code
- GGN
- 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 deviceK992278 Heparin Control Plasma Level 1Pacific Hemostasis · 1999
- 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) | K992278 | Heparin Control Plasma Level 1 | Pacific Hemostasis | 1999 | — |
| +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 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 |
|---|---|---|---|
| * | K771346 | CI-Trol Coagulation Controls II & IiiSummary page 1…trol Plasma Level | Common Name: Heparin Control Plasma Level 1 Classification Name: Piasma, Coigulation Control i Equivalent Device: Dade Ci-Trol Heparin Control Low, K771346 | Description of Heparin Control Level 1 Pacific Hemostasis Heparin Control Level 1 is a lyophilized preparation of citrated pl… | 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 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 | — |
What is it indicated for?
Pacific Hemostasis Heparin Control Plasma Level 1, an unassayed control plasma, is intended for use as a control in heparin assay procedures.
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/K992278 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992278: Heparin Control Plasma Level 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992278
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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