FDA product code KFZ: Humidifier, Non-Direct Patient Interface (Home-Use)
KFZ is the FDA product code for humidifier, non-direct patient interface (home-use). It is a Class I device, regulated under 21 CFR 868.5460 and reviewed by the Anesthesiology panel. FDA has cleared 20 510(k) submissions under KFZ, from 17 different applicants. The average 510(k) review took 76 days (median 51). FDA has posted 3 recalls for KFZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Humidifier, Non-Direct Patient Interface (Home-Use) |
| Device class | Class I |
| Regulation | 21 CFR 868.5460 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KFZ clearance
Top KFZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Associated Mills, Inc. | 2 | 1987-06-15 |
| Airlife, Inc. | 2 | 1983-04-18 |
| Mistogen Equipment Co. | 2 | 1978-10-16 |
| Kaz, Inc. | 1 | 1995-02-10 |
| Virotherm Laboratory | 1 | 1992-10-22 |
12 more applicants have KFZ clearances. See the full list in Caduvo.
Most recent KFZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950116 | Kaz, Inc. | THERASTEAM PERSONAL STEAM INHALER | 1995-02-10 | 30 |
| K915603 | Virotherm Laboratory | VIROTHERM HUMIDIFIER | 1992-10-22 | 311 |
| K894734 | Twinmed Products, Inc. | RHINOTHERM ULTRA 2 | 1990-02-16 | 207 |
| K871661 | Associated Mills, Inc. | WH150 ROOM HUMIDIFIER | 1987-06-15 | 48 |
| K871189 | Sunbeam Appliance Service Co. | SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380 | 1987-05-08 | 45 |
Recalls for KFZ devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-03-16.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code KFZ?
KFZ is the FDA product code for humidifier, non-direct patient interface (home-use). It is a Class I device, regulated under 21 CFR 868.5460 and reviewed by the Anesthesiology panel.
What device class is KFZ?
Class I, regulation 21 CFR 868.5460. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KFZ?
Across 20 cleared submissions the average was 76 days from receipt to decision (median 51).
Which companies have the most KFZ clearances?
Associated Mills, Inc. (2); Airlife, Inc. (2); Mistogen Equipment Co. (2); Kaz, Inc. (1); Virotherm Laboratory (1).
Have KFZ devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2021-03-16.
Next steps
- Run an FDA pathway report with predicate devices for product code KFZ
- Run a recall and safety report across every KFZ manufacturer
- Watch product code KFZ 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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