FDA product code BYX: Tubing, Pressure And Accessories
BYX is the FDA product code for tubing, pressure and accessories. It is a Class I device, regulated under 21 CFR 868.5860 and reviewed by the Anesthesiology panel. FDA has cleared 62 510(k) submissions under BYX, from 33 different applicants. The average 510(k) review took 39 days (median 27). FDA has posted 1 recall for BYX devices.
Classification
| Field | Value |
|---|---|
| Device name | Tubing, Pressure And Accessories |
| Device class | Class I |
| Regulation | 21 CFR 868.5860 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BYX clearance
Top BYX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Fittings, Inc. | 12 | 1993-06-01 |
| Airlife, Inc. | 7 | 1980-05-23 |
| Timeter Instrument Corp. | 5 | 1981-12-08 |
| Todd Industries, Inc. | 3 | 1981-03-17 |
| Mem Medical, Inc. | 3 | 1979-10-01 |
28 more applicants have BYX clearances. See the full list in Caduvo.
Most recent BYX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K011134 | Hudson Respiratory Care, Inc. | OXYGEN SUPPLY TUBING, MODEL 1115 | 2001-06-13 | 61 |
| K955656 | North State Plastics, Inc. | NORTH STATE PLASTICS AEROSOL TEE | 1996-03-06 | 85 |
| K943110 | Coast Medical, Inc. | GAS SAMPLING INTERFACES | 1994-08-19 | 51 |
| K935835 | Busse Hospital Disposables, Inc. | BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES | 1994-01-12 | 36 |
| K931043 | Medical Fittings, Inc. | MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS | 1993-06-01 | 92 |
Recalls for BYX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-08-10.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code BYX?
BYX is the FDA product code for tubing, pressure and accessories. It is a Class I device, regulated under 21 CFR 868.5860 and reviewed by the Anesthesiology panel.
What device class is BYX?
Class I, regulation 21 CFR 868.5860. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BYX?
Across 62 cleared submissions the average was 39 days from receipt to decision (median 27).
Which companies have the most BYX clearances?
Medical Fittings, Inc. (12); Airlife, Inc. (7); Timeter Instrument Corp. (5); Todd Industries, Inc. (3); Mem Medical, Inc. (3).
Have BYX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-08-10.
Next steps
- Run an FDA pathway report with predicate devices for product code BYX
- Run a recall and safety report across every BYX manufacturer
- Watch product code BYX 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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