FDA product code KZF: Device, Medical Examination, Ac Powered
KZF is the FDA product code for device, medical examination, ac powered. It is a Class I device, regulated under 21 CFR 880.6320 and reviewed by the General Hospital panel. FDA has cleared 37 510(k) submissions under KZF, from 18 different applicants. The average 510(k) review took 131 days (median 110). FDA has posted 5 recalls for KZF devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Medical Examination, Ac Powered |
| Device class | Class I |
| Regulation | 21 CFR 880.6320 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KZF clearance
Top KZF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Illumination, Inc. | 8 | 1993-08-19 |
| Burton Medical Products Corp. | 7 | 1994-04-26 |
| Welch Allyn, Inc. | 6 | 1995-09-22 |
| Meddev International Corp. | 2 | 1994-02-28 |
| Nizar A. Mullani | 1 | 1996-03-27 |
13 more applicants have KZF clearances. See the full list in Caduvo.
Most recent KZF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K954943 | Nizar A. Mullani | NEVOSCOPE | 1996-03-27 | 149 |
| K952835 | Welch Allyn, Inc. | WELCH ALLYN VIDEO EPISCOPE | 1995-09-22 | 94 |
| K945507 | Rudolf Riester GmbH & Co. KG | H 5100, H 5200, H 5300 | 1994-12-09 | 30 |
| K941869 | The Lighthouse For the Blind, Inc. | SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG | 1994-08-03 | 107 |
| K936088 | Burton Medical Products Corp. | WAVE FLUORESCENT MAGNIFIER | 1994-04-26 | 126 |
Recalls for KZF devices
5 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-10-13.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code KZF?
KZF is the FDA product code for device, medical examination, ac powered. It is a Class I device, regulated under 21 CFR 880.6320 and reviewed by the General Hospital panel.
What device class is KZF?
Class I, regulation 21 CFR 880.6320. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KZF?
Across 37 cleared submissions the average was 131 days from receipt to decision (median 110).
Which companies have the most KZF clearances?
Medical Illumination, Inc. (8); Burton Medical Products Corp. (7); Welch Allyn, Inc. (6); Meddev International Corp. (2); Nizar A. Mullani (1).
Have KZF devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2025-10-13.
Next steps
- Run an FDA pathway report with predicate devices for product code KZF
- Run a recall and safety report across every KZF manufacturer
- Watch product code KZF 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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