FDA product code BYF: Mask, Oxygen, Low Concentration, Venturi
BYF is the FDA product code for mask, oxygen, low concentration, venturi. It is a Class I device, regulated under 21 CFR 868.5600 and reviewed by the Anesthesiology panel. FDA has cleared 19 510(k) submissions under BYF, from 12 different applicants. The average 510(k) review took 41 days (median 33). FDA has posted 3 recalls for BYF devices.
Classification
| Field | Value |
|---|---|
| Device name | Mask, Oxygen, Low Concentration, Venturi |
| Device class | Class I |
| Regulation | 21 CFR 868.5600 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BYF clearance
Top BYF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Airlife, Inc. | 5 | 1983-09-20 |
| Hospitak, Inc. | 2 | 1996-02-28 |
| Dhd Medical Products Div. Diemolding Corp. | 2 | 1986-03-20 |
| Todd Industries, Inc. | 2 | 1981-03-17 |
| Flexicare Medical, Ltd. | 1 | 1995-04-27 |
7 more applicants have BYF clearances. See the full list in Caduvo.
Most recent BYF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K955483 | Hospitak, Inc. | TRACH MASK MODEL (245, 246) | 1996-02-28 | 89 |
| K951652 | Flexicare Medical, Ltd. | VENTIMASK MK IV | 1995-04-27 | 17 |
| K894457 | Dadsun Corp., Ltd. | CARNATION TRACHEOSTOMY MASKS | 1989-10-13 | 87 |
| K860873 | Dhd Medical Products Div. Diemolding Corp. | VENTURI MASK/ADULT & PAEDIATRIC | 1986-03-20 | 23 |
| K860874 | Dhd Medical Products Div. Diemolding Corp. | VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC | 1986-03-19 | 22 |
Recalls for BYF devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-03-25.
Frequently asked questions
What is FDA product code BYF?
BYF is the FDA product code for mask, oxygen, low concentration, venturi. It is a Class I device, regulated under 21 CFR 868.5600 and reviewed by the Anesthesiology panel.
What device class is BYF?
Class I, regulation 21 CFR 868.5600. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BYF?
Across 19 cleared submissions the average was 41 days from receipt to decision (median 33).
Which companies have the most BYF clearances?
Airlife, Inc. (5); Hospitak, Inc. (2); Dhd Medical Products Div. Diemolding Corp. (2); Todd Industries, Inc. (2); Flexicare Medical, Ltd. (1).
Have BYF devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2011-03-25.
Next steps
- Run an FDA pathway report with predicate devices for product code BYF
- Run a recall and safety report across every BYF manufacturer
- Watch product code BYF 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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