FDA product code BYY: Tube, Aspirating, Flexible, Connecting
BYY is the FDA product code for tube, aspirating, flexible, connecting. It is a Class II device, regulated under 21 CFR 880.6740 and reviewed by the General Hospital panel. FDA has cleared 24 510(k) submissions under BYY, from 19 different applicants. The average 510(k) review took 70 days (median 49). FDA has posted 6 recalls for BYY devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tube, Aspirating, Flexible, Connecting |
| Device class | Class II |
| Regulation | 21 CFR 880.6740 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BYY clearance
Top BYY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Medical Devices, Inc. | 3 | 1996-01-24 |
| Mgn Medical Manufacturing, Inc. | 2 | 1982-06-22 |
| American Pharmaseal Div. Ahsc | 2 | 1982-04-01 |
| Snyder Laboratories, Inc. | 2 | 1979-04-23 |
| Vital Concepts, Inc. | 1 | 1996-05-06 |
14 more applicants have BYY clearances. See the full list in Caduvo.
Most recent BYY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K960616 | Vital Concepts, Inc. | VITAFLOW SUCTION/ASPIRATION TUBING SET | 1996-05-06 | 83 |
| K960218 | Custom Pack Reliability | CONNECTING TUBING | 1996-03-28 | 72 |
| K955151 | Bio-Medical Devices, Inc. | MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR | 1996-01-24 | 72 |
| K955149 | Bio-Medical Devices, Inc. | MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL | 1996-01-24 | 72 |
| K955150 | Bio-Medical Devices, Inc. | MAXI-FLOW | 1996-01-23 | 71 |
Recalls for BYY devices
6 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-01-15.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code BYY?
BYY is the FDA product code for tube, aspirating, flexible, connecting. It is a Class II device, regulated under 21 CFR 880.6740 and reviewed by the General Hospital panel.
What device class is BYY?
Class II, regulation 21 CFR 880.6740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BYY?
Across 24 cleared submissions the average was 70 days from receipt to decision (median 49).
Which companies have the most BYY clearances?
Bio-Medical Devices, Inc. (3); Mgn Medical Manufacturing, Inc. (2); American Pharmaseal Div. Ahsc (2); Snyder Laboratories, Inc. (2); Vital Concepts, Inc. (1).
Have BYY devices been recalled?
Yes: 6 product recalls across 3 recall events; the most recent began 2025-01-15.
Next steps
- Run an FDA pathway report with predicate devices for product code BYY
- Run a recall and safety report across every BYY manufacturer
- Watch product code BYY 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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