510(k) · Cleared
ClearedI-Stat Activated Clotting Time (Act) Control Set Level 1 and Level 2, Models 07G82-01, 07G82-02
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad, Diagnostics Grp. · GGN Plasma, Coagulation Control
Cleared on Jun 26, 2007 as substantially equivalent to K981752 (Biopool Intl., Inc., 1998) after a 47-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jun 26, 2007
- Review
- 47 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981752 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK981752 I-Stat Coagulation Control SetBiopool Intl., Inc. · 1998
- This deviceK071319 I-Stat Activated Clotting Time (Act) Control Set Level 1 and Level…Bio-Rad, Diagnostics Grp. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981752 | I-Stat Coagulation Control Set | Biopool Intl., Inc. | 1998 | — |
| 0 (this device) | K071319 | I-Stat Activated Clotting Time (Act) Control Set Level 1 and Level 2, Models… | Bio-Rad, Diagnostics Grp. | 2007 | — |
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 |
|---|---|---|---|
| * | K981752 | I-Stat Coagulation Control SetSummary page 1…aimed i-STAT COAGULATION CONTROL SET BIOPOOL INTL., INC. 6025 Nicolle St. Ventura, CA 93003 510 (k) Number: K981752 4.0 Description of Device This is a Iyophilized product prepared from human plasma, with added purified… | 1998 |
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. 2007, 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?
i-STAT® Activated Clotting Time (ACT) Control is used to verify the integrity of newly received i-STAT® Activated Clotting Time cartridges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071319: I-Stat Activated Clotting Time (Act) Control Set Level 1 and Level 2, Models 07G82-01, 07G82-02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071319
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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