FDA product code KFF: Assay, Heparin
KFF is the FDA product code for assay, heparin. It is a Class II device, regulated under 21 CFR 864.7525 and reviewed by the Hematology panel. FDA has cleared 46 510(k) submissions under KFF, 1 in the last five years, from 29 different applicants. The average 510(k) review took 206 days (median 127). FDA has posted 12 recalls for KFF devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Assay, Heparin |
| Device class | Class II |
| Regulation | 21 CFR 864.7525 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KFF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 344 |
| 2022 | 1 | 341 |
Compare with all 510(k) review times · Search every KFF clearance
Top KFF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Bioproducts Co. | 8 | 1995-09-26 |
| Instrumentation Laboratory CO | 6 | 2022-10-04 |
| Cardiovascular Diagnostics, Inc. | 2 | 2002-08-23 |
| American Diagnostica, Inc. | 2 | 2002-04-16 |
| International Technidyne Corp. | 2 | 2001-06-06 |
24 more applicants have KFF clearances. See the full list in Caduvo.
Most recent KFF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K213464 | Instrumentation Laboratory CO | HemosIL Liquid Anti-Xa | 2022-10-04 | 341 |
| K162540 | Siemens Healthcare Diagnostics Prodcts GmbH | INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls | 2017-08-22 | 344 |
| K111822 | Diagnostica Stago, Inc. | STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH | 2011-10-26 | 120 |
| K090209 | Instrumentation Laboratory CO | HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS | 2009-06-02 | 125 |
| K050367 | Hyphen Biomed | BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 | 2006-05-24 | 464 |
Recalls for KFF devices
12 product recalls in 8 recall events; 8 initiated in the last five years and 9 still open. Most recent: 2025-07-21.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2023 | 4 |
| 2024 | 1 |
| 2025 | 3 |
Frequently asked questions
What is FDA product code KFF?
KFF is the FDA product code for assay, heparin. It is a Class II device, regulated under 21 CFR 864.7525 and reviewed by the Hematology panel.
What device class is KFF?
Class II, regulation 21 CFR 864.7525. Typical premarket route: 510(k).
How long does a 510(k) take for product code KFF?
Across 46 cleared submissions the average was 206 days from receipt to decision (median 127).
Which companies have the most KFF clearances?
American Bioproducts Co. (8); Instrumentation Laboratory CO (6); Cardiovascular Diagnostics, Inc. (2); American Diagnostica, Inc. (2); International Technidyne Corp. (2).
Have KFF devices been recalled?
Yes: 12 product recalls across 8 recall events; the most recent began 2025-07-21.
Next steps
- Run an FDA pathway report with predicate devices for product code KFF
- Run a recall and safety report across every KFF manufacturer
- Watch product code KFF 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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