FDA product code BYS: Oxygenator, Long Term Support Greater Than 6 Hours
BYS is the FDA product code for oxygenator, long term support greater than 6 hours. It is a Class II device, regulated under 21 CFR 870.4100 and reviewed by the Cardiovascular panel. FDA has cleared 3 510(k) submissions under BYS, 1 in the last five years, from 3 different applicants. The average 510(k) review took 132 days (median 108). FDA has posted 2 recalls for BYS devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Oxygenator, Long Term Support Greater Than 6 Hours |
| Device class | Class II |
| Regulation | 21 CFR 870.4100 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for BYS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 265 |
| 2023 | 1 | 23 |
Compare with all 510(k) review times · Search every BYS clearance
Top BYS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mc3, Inc. | 1 | 2023-10-04 |
| Mc3 Incorporated | 1 | 2020-04-09 |
| William Harvey Life Products Corp. | 1 | 1977-08-04 |
Most recent BYS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232767 | Mc3, Inc. | Nautilus VF ECMO Oxygenator | 2023-10-04 | 23 |
| K191935 | Mc3 Incorporated | Nautilus Smart ECMO Module | 2020-04-09 | 265 |
| K770720 | William Harvey Life Products Corp. | TUBING PACK, EXTRACORPOREAL, H-3000 | 1977-08-04 | 108 |
Recalls for BYS devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-10-11.
| Year | Recalls |
|---|---|
| 2023 | 2 |
Frequently asked questions
What is FDA product code BYS?
BYS is the FDA product code for oxygenator, long term support greater than 6 hours. It is a Class II device, regulated under 21 CFR 870.4100 and reviewed by the Cardiovascular panel.
What device class is BYS?
Class II, regulation 21 CFR 870.4100. Typical premarket route: 510(k).
How long does a 510(k) take for product code BYS?
Across 3 cleared submissions the average was 132 days from receipt to decision (median 108).
Which companies have the most BYS clearances?
Mc3, Inc. (1); Mc3 Incorporated (1); William Harvey Life Products Corp. (1).
Have BYS devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2023-10-11.
Next steps
- Run an FDA pathway report with predicate devices for product code BYS
- Run a recall and safety report across every BYS manufacturer
- Watch product code BYS 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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