FDA product code BYH: Drain, Tee (Water Trap)
BYH is the FDA product code for drain, tee (water trap). It is a Class I device, regulated under 21 CFR 868.5995 and reviewed by the Anesthesiology panel. FDA has cleared 22 510(k) submissions under BYH, from 13 different applicants. The average 510(k) review took 54 days (median 38). FDA has posted 2 recalls for BYH devices.
Classification
| Field | Value |
|---|---|
| Device name | Drain, Tee (Water Trap) |
| Device class | Class I |
| Regulation | 21 CFR 868.5995 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Top BYH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dhd Medical Products Div. Diemolding Corp. | 5 | 1987-10-30 |
| Thayer Medical Corp. | 4 | 1990-04-23 |
| Intertech Resources, Inc. | 2 | 1992-06-30 |
| Airlife, Inc. | 2 | 1984-03-05 |
| Pegasus Research Corp. | 1 | 1995-05-05 |
8 more applicants have BYH clearances. See the full list in Caduvo.
Most recent BYH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K946057 | Pegasus Research Corp. | AQUALARM MOISTURE SENSOR MODEL P85000 | 1995-05-05 | 144 |
| K932722 | Carie Med-Tech Services, Inc. | CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEM | 1993-08-06 | 63 |
| K921624 | Intertech Resources, Inc. | DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS | 1992-06-30 | 85 |
| K900047 | Thayer Medical Corp. | THAYER SUCTION EVACUATION CONDENSATE COLLECTION | 1990-04-23 | 110 |
| K897057 | Thayer Medical Corp. | THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM | 1990-03-16 | 88 |
Recalls for BYH devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-07-12.
Frequently asked questions
What is FDA product code BYH?
BYH is the FDA product code for drain, tee (water trap). It is a Class I device, regulated under 21 CFR 868.5995 and reviewed by the Anesthesiology panel.
What device class is BYH?
Class I, regulation 21 CFR 868.5995. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BYH?
Across 22 cleared submissions the average was 54 days from receipt to decision (median 38).
Which companies have the most BYH clearances?
Dhd Medical Products Div. Diemolding Corp. (5); Thayer Medical Corp. (4); Intertech Resources, Inc. (2); Airlife, Inc. (2); Pegasus Research Corp. (1).
Have BYH devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2004-07-12.
Next steps
- Run an FDA pathway report with predicate devices for product code BYH
- Run a recall and safety report across every BYH manufacturer
- Watch product code BYH 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.