FDA product code CFR: Hexokinase, Glucose
CFR is the FDA product code for hexokinase, glucose. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel. FDA has cleared 145 510(k) submissions under CFR, 3 in the last five years, from 86 different applicants. The average 510(k) review took 91 days (median 63); 99 days on average over the last three years. FDA has posted 22 recalls for CFR devices.
Classification
| Field | Value |
|---|---|
| Device name | Hexokinase, Glucose |
| Device class | Class II |
| Regulation | 21 CFR 862.1345 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CFR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 260 |
| 2019 | 1 | 31 |
| 2022 | 1 | 241 |
| 2025 | 1 | 87 |
| 2026 | 1 | 111 |
Compare with all 510(k) review times · Search every CFR clearance
Top CFR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 7 | 1993-07-22 |
| Abbott Laboratories | 6 | 2017-10-19 |
| Heraeus Kulzer, Inc. | 6 | 1995-06-01 |
| Harleco | 6 | 1981-09-29 |
| Roche Diagnostics | 4 | 2026-02-12 |
81 more applicants have CFR clearances. See the full list in Caduvo.
Most recent CFR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253490 | Roche Diagnostics | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | 2026-02-12 | 111 |
| K252357 | Abbott Ireland | Glucose2 | 2025-10-24 | 87 |
| K220134 | Roche Diagnostics | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH | 2022-09-16 | 241 |
| K191899 | Roche Diagnostics | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions | 2019-08-16 | 31 |
| K170316 | Abbott Laboratories | ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM | 2017-10-19 | 260 |
Recalls for CFR devices
22 product recalls in 9 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-06-29.
| Year | Recalls |
|---|---|
| 2017 | 2 |
Frequently asked questions
What is FDA product code CFR?
CFR is the FDA product code for hexokinase, glucose. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel.
What device class is CFR?
Class II, regulation 21 CFR 862.1345. Typical premarket route: 510(k).
How long does a 510(k) take for product code CFR?
Across 145 cleared submissions the average was 91 days from receipt to decision (median 63).
Which companies have the most CFR clearances?
Em Diagnostic Systems, Inc. (7); Abbott Laboratories (6); Heraeus Kulzer, Inc. (6); Harleco (6); Roche Diagnostics (4).
Have CFR devices been recalled?
Yes: 22 product recalls across 9 recall events; the most recent began 2017-06-29.
Next steps
- Run an FDA pathway report with predicate devices for product code CFR
- Run a recall and safety report across every CFR manufacturer
- Watch product code CFR 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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