FDA product code BYI: Percussor, Powered-Electric
BYI is the FDA product code for percussor, powered-electric. It is a Class II device, regulated under 21 CFR 868.5665 and reviewed by the Anesthesiology panel. FDA has cleared 58 510(k) submissions under BYI, 6 in the last five years, from 43 different applicants. The average 510(k) review took 120 days (median 86); 206 days on average over the last three years. FDA has posted 3 recalls for BYI devices.
Classification
| Field | Value |
|---|---|
| Device name | Percussor, Powered-Electric |
| Device class | Class II |
| Regulation | 21 CFR 868.5665 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BYI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 106 |
| 2018 | 1 | 337 |
| 2021 | 2 | 165 |
| 2022 | 1 | 92 |
| 2024 | 3 | 189 |
| 2025 | 1 | 195 |
| 2026 | 1 | 234 |
Compare with all 510(k) review times · Search every BYI clearance
Top BYI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Electromed, Inc. | 5 | 2022-11-18 |
| American Biosystems, Inc. | 4 | 2000-01-21 |
| Dymedso, Inc. | 3 | 2011-01-26 |
| Strom Corp. | 3 | 1982-07-26 |
| Advanced Respiratory | 2 | 2003-02-21 |
38 more applicants have BYI clearances. See the full list in Caduvo.
Most recent BYI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252849 | Tactile Medical | AffloVest® Mobile Airway Clearance Therapy | 2026-04-30 | 234 |
| K250860 | Exemplar Medical, LLC | BreatheBand® (Model 1000) | 2025-10-02 | 195 |
| K242063 | Synchrony Medical , Ltd. | LibAirty Airway Clearance System | 2024-12-19 | 157 |
| K240959 | Chongqing Moffy Innovation Technology Co., Ltd. | Respiratory Muscle Trainer | 2024-12-18 | 254 |
| K233441 | Baxter Healthcare Corportation | The Vest APX System (PVAPX1) | 2024-03-22 | 156 |
Recalls for BYI devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-03-31.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code BYI?
BYI is the FDA product code for percussor, powered-electric. It is a Class II device, regulated under 21 CFR 868.5665 and reviewed by the Anesthesiology panel.
What device class is BYI?
Class II, regulation 21 CFR 868.5665. Typical premarket route: 510(k).
How long does a 510(k) take for product code BYI?
Across 58 cleared submissions the average was 120 days from receipt to decision (median 86).
Which companies have the most BYI clearances?
Electromed, Inc. (5); American Biosystems, Inc. (4); Dymedso, Inc. (3); Strom Corp. (3); Advanced Respiratory (2).
Have BYI devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2021-03-31.
Next steps
- Run an FDA pathway report with predicate devices for product code BYI
- Run a recall and safety report across every BYI manufacturer
- Watch product code BYI 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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