FDA product code BYE: Attachment, Breathing, Positive End Expiratory Pressure
BYE is the FDA product code for attachment, breathing, positive end expiratory pressure. It is a Class II device, regulated under 21 CFR 868.5965 and reviewed by the Anesthesiology panel. FDA has cleared 80 510(k) submissions under BYE, from 56 different applicants. The average 510(k) review took 93 days (median 79). FDA has posted 10 recalls for BYE devices.
Classification
| Field | Value |
|---|---|
| Device name | Attachment, Breathing, Positive End Expiratory Pressure |
| Device class | Class II |
| Regulation | 21 CFR 868.5965 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every BYE clearance
Top BYE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vital Signs, Inc. | 6 | 1991-09-11 |
| Puritan Bennett Corp. | 5 | 1992-05-29 |
| Respironics, Inc. | 5 | 1990-03-28 |
| Devilbiss Health Care, Inc. | 3 | 1989-09-18 |
| Life Design Systems, Inc. | 3 | 1986-07-14 |
51 more applicants have BYE clearances. See the full list in Caduvo.
Most recent BYE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K160112 | Besmed Health Business Corp | Besmed PEEP Valve | 2016-04-29 | 101 |
| K133957 | Galemed Corp. | DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE | 2014-04-14 | 112 |
| K133210 | S & T Medical Technologies, Inc. | B&B BUBBLER | 2014-03-28 | 162 |
| K122610 | Sen MU Technology Co., Ltd. | PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES | 2013-08-05 | 343 |
| K112546 | O-Two Medical Technologies, Inc. | O_TWO CPAP SYSTEM | 2011-12-27 | 117 |
Recalls for BYE devices
10 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-01-15.
| Year | Recalls |
|---|---|
| 2019 | 3 |
Frequently asked questions
What is FDA product code BYE?
BYE is the FDA product code for attachment, breathing, positive end expiratory pressure. It is a Class II device, regulated under 21 CFR 868.5965 and reviewed by the Anesthesiology panel.
What device class is BYE?
Class II, regulation 21 CFR 868.5965. Typical premarket route: 510(k).
How long does a 510(k) take for product code BYE?
Across 80 cleared submissions the average was 93 days from receipt to decision (median 79).
Which companies have the most BYE clearances?
Vital Signs, Inc. (6); Puritan Bennett Corp. (5); Respironics, Inc. (5); Devilbiss Health Care, Inc. (3); Life Design Systems, Inc. (3).
Have BYE devices been recalled?
Yes: 10 product recalls across 4 recall events; the most recent began 2019-01-15.
Next steps
- Run an FDA pathway report with predicate devices for product code BYE
- Run a recall and safety report across every BYE manufacturer
- Watch product code BYE 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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