FDA product code GFO: Activated Partial Thromboplastin
GFO is the FDA product code for activated partial thromboplastin. It is a Class II device, regulated under 21 CFR 864.7925 and reviewed by the Hematology panel. FDA has cleared 52 510(k) submissions under GFO, 1 in the last five years, from 32 different applicants. The average 510(k) review took 100 days (median 78); 30 days on average over the last three years. FDA has posted 10 recalls for GFO devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Activated Partial Thromboplastin |
| Device class | Class II |
| Regulation | 21 CFR 864.7925 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GFO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 305 |
| 2026 | 1 | 30 |
Compare with all 510(k) review times · Search every GFO clearance
Top GFO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| International Technidyne Corp. | 5 | 1997-11-20 |
| Analytical Control Systems, Inc. | 5 | 1997-03-07 |
| Instrumentation Laboratory CO | 4 | 2016-03-16 |
| Medical Diagnostic Technologies, Inc. | 3 | 1993-12-06 |
| Sigma Diagnostics, Inc. | 2 | 1999-12-06 |
27 more applicants have GFO clearances. See the full list in Caduvo.
Most recent GFO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253957 | Instrumentation Laboratory (IL) Co. | HemosIL Silica Clotting Time | 2026-01-09 | 30 |
| K193556 | Precision Biologic | Cryocheck Hex LA | 2020-10-23 | 305 |
| K160445 | Instrumentation Laboratory CO | HemosIL Silica Clotting Time | 2016-03-16 | 28 |
| K053111 | Diagnostica Stago, Inc. | STA-CEPHASCREEN KIT | 2006-05-04 | 181 |
| K060688 | Instrumentation Laboratory CO | HEMOSIL SYNTHASIL | 2006-04-13 | 29 |
Recalls for GFO devices
10 product recalls in 9 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-12-11.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 2 |
| 2021 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code GFO?
GFO is the FDA product code for activated partial thromboplastin. It is a Class II device, regulated under 21 CFR 864.7925 and reviewed by the Hematology panel.
What device class is GFO?
Class II, regulation 21 CFR 864.7925. Typical premarket route: 510(k).
How long does a 510(k) take for product code GFO?
Across 52 cleared submissions the average was 100 days from receipt to decision (median 78).
Which companies have the most GFO clearances?
International Technidyne Corp. (5); Analytical Control Systems, Inc. (5); Instrumentation Laboratory CO (4); Medical Diagnostic Technologies, Inc. (3); Sigma Diagnostics, Inc. (2).
Have GFO devices been recalled?
Yes: 10 product recalls across 9 recall events; the most recent began 2025-12-11.
Next steps
- Run an FDA pathway report with predicate devices for product code GFO
- Run a recall and safety report across every GFO manufacturer
- Watch product code GFO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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