BYH · Drain, Tee (Water Trap)
Anesthesiology · 21 CFR 868.5995 · Class 1
Overview
| Product Code | BYH |
|---|---|
| Device Name | Drain, Tee (Water Trap) |
| Regulation | 21 CFR 868.5995 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A tee drain (water trap) is a device intended to trap and drain water that collects in ventilator tubing during respiratory therapy, thereby preventing an increase in breathing resistance.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Recent Cleared Devices (20 of 22)
Showing 20 most recent of 22 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K946057 | AQUALARM MOISTURE SENSOR MODEL P85000 | Pegasus Research Corp. | May 5, 1995 | SESE |
| K932722 | CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEM | Carie Med-Tech Services, Inc. | Aug 6, 1993 | SESE |
| K921624 | DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS | Intertech Resources, Inc. | Jun 30, 1992 | SESE |
| K900047 | THAYER SUCTION EVACUATION CONDENSATE COLLECTION | Thayer Medical Corp. | Apr 23, 1990 | SESE |
| K897057 | THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM | Thayer Medical Corp. | Mar 16, 1990 | SESE |
| K900591 | VENT-TRAP CAT# WR1000 | Ventlab Corp. | Mar 9, 1990 | SESE |
| K895479 | THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM | Thayer Medical Corp. | Mar 9, 1990 | SESE |
| K885088 | THAYER FLEXIBLE CONDENSATE COLLECTION SYSTEM | Thayer Medical Corp. | Jan 12, 1989 | SESE |
| K882739 | INTERTECH LARGE VOLUME WATER TRAP (LVW) | Intertech Resources, Inc. | Aug 9, 1988 | SESE |
| K881790 | SAFETY DRAIN | Ballard Medical Products | Jun 21, 1988 | SESE |
| K873447 | DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR | Dhd Medical Products Div. Diemolding Corp. | Oct 30, 1987 | SESE |
| K864147 | AQUAVALVE | Respiratory Care, Inc. | Dec 5, 1986 | SESE |
| K860884 | SELF-SEALING WATER TRAP/ACCESSORIES | Dhd Medical Products Div. Diemolding Corp. | Mar 19, 1986 | SESE |
| K860883 | SELF-SEALING WATER TRAP/ADULT/PAEDIATRIC CIRCUITS | Dhd Medical Products Div. Diemolding Corp. | Mar 19, 1986 | SESE |
| K853665 | SPLASH ADAPTOR | Ohio Medical Research, Inc. | Oct 10, 1985 | SESE |
| K834573 | AQUA TRAP | Airlife, Inc. | Mar 5, 1984 | SESE |
| K820936 | MOISTURE TRAP | Dhd Medical Products Div. Diemolding Corp. | Apr 29, 1982 | SESE |
| K812569 | SHERWOOD WATER TRAP | Sherwood Medical Co. | Sep 25, 1981 | SESE |
| K800990 | TRACH MIST UNIT W/OR WITHOUT ELBOW | Airlife, Inc. | May 8, 1980 | SESE |
| K792390 | MOISTURE TRAP | Dhd Medical Products Div. Diemolding Corp. | Dec 4, 1979 | SESE |
Top Applicants
- Dhd Medical Products Div. Diemolding Corp. — 5 clearances
- Thayer Medical Corp. — 4 clearances
- Airlife, Inc. — 2 clearances
- Intertech Resources, Inc. — 2 clearances
- Ballard Medical Products — 1 clearance
