FDA product code BYD: Condenser, Heat And Moisture (Artificial Nose)
BYD is the FDA product code for condenser, heat and moisture (artificial nose). It is a Class I device, regulated under 21 CFR 868.5375 and reviewed by the Anesthesiology panel. FDA has cleared 73 510(k) submissions under BYD, from 33 different applicants. The average 510(k) review took 75 days (median 63). FDA has posted 15 recalls for BYD devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Condenser, Heat And Moisture (Artificial Nose) |
| Device class | Class I |
| Regulation | 21 CFR 868.5375 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BYD clearance
Top BYD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Icor AB | 9 | 1995-09-07 |
| Gibeck, Inc. | 7 | 1995-08-25 |
| Gibeck Respiration | 6 | 1988-06-24 |
| Mallinckrodt Medical | 5 | 1995-06-08 |
| Artema Medical AB | 5 | 1995-02-21 |
28 more applicants have BYD clearances. See the full list in Caduvo.
Most recent BYD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K955008 | Intertech Resources, Inc. | HEAT & MOISTURE EXCHANGER | 1996-01-30 | 90 |
| K954194 | Engstrom Medical | DISPOSABLE HME/FILTER | 1995-10-20 | 44 |
| K953580 | Intertech Resources, Inc. | HEAT MOISTURE EXCHANGER | 1995-09-15 | 45 |
| K953507 | Icor AB | TYPE 1 & 2 (HUMIDAIR I & II) | 1995-09-07 | 43 |
| K953620 | Hospitak, Inc. | WARM N WET HMEF W/LUER ADAPTER | 1995-08-25 | 22 |
Recalls for BYD devices
15 product recalls in 11 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2024-07-18.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 3 |
Frequently asked questions
What is FDA product code BYD?
BYD is the FDA product code for condenser, heat and moisture (artificial nose). It is a Class I device, regulated under 21 CFR 868.5375 and reviewed by the Anesthesiology panel.
What device class is BYD?
Class I, regulation 21 CFR 868.5375. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BYD?
Across 73 cleared submissions the average was 75 days from receipt to decision (median 63).
Which companies have the most BYD clearances?
Icor AB (9); Gibeck, Inc. (7); Gibeck Respiration (6); Mallinckrodt Medical (5); Artema Medical AB (5).
Have BYD devices been recalled?
Yes: 15 product recalls across 11 recall events; the most recent began 2024-07-18.
Next steps
- Run an FDA pathway report with predicate devices for product code BYD
- Run a recall and safety report across every BYD manufacturer
- Watch product code BYD 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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