Product Code: BYH FDA class 1 21 CFR 868.5995

Drain, Tee (Water Trap)

Anesthesiology

The Drain, Tee (Water Trap) is a device incorporated into respiratory circuits or gas sampling lines to collect and remove condensed water, preventing moisture from entering measuring instruments or contaminating gas flow pathways. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BYH, regulated under 21 CFR 868.5995 in the Anesthesiology specialty.

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510(k)s

FEI Numbers

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Unique Applicants

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Basic Information

Product Code: BYH
Device Class: FDA class 1
Regulation Number: 868.5995
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 22 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K946057	AQUALARM MOISTURE SENSOR MODEL P85000	May 05, 1995	Substantially Equivalent	Pegasus Research Corp.
K932722	CARIE MED-TECH MODEL 210 RAINOUT DRAINAGE SYSTEM	Aug 06, 1993	Substantially Equivalent	Carie Med-Tech Services, Inc.
K921624	DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS	Jun 30, 1992	Substantially Equivalent	Intertech Resources, Inc.
K900047	THAYER SUCTION EVACUATION CONDENSATE COLLECTION	Apr 23, 1990	Substantially Equivalent	Thayer Medical Corp.
K897057	THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM	Mar 16, 1990	Substantially Equivalent	Thayer Medical Corp.
K900591	VENT-TRAP CAT# WR1000	Mar 09, 1990	Substantially Equivalent	Ventlab Corp.
K895479	THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM	Mar 09, 1990	Substantially Equivalent	Thayer Medical Corp.
K885088	THAYER FLEXIBLE CONDENSATE COLLECTION SYSTEM	Jan 12, 1989	Substantially Equivalent	Thayer Medical Corp.
K882739	INTERTECH LARGE VOLUME WATER TRAP (LVW)	Aug 09, 1988	Substantially Equivalent	Intertech Resources, Inc.
K881790	SAFETY DRAIN	Jun 21, 1988	Substantially Equivalent	Ballard Medical Products
K873447	DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR	Oct 30, 1987	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K864147	AQUAVALVE	Dec 05, 1986	Substantially Equivalent	Respiratory Care, Inc.
K860884	SELF-SEALING WATER TRAP/ACCESSORIES	Mar 19, 1986	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K860883	SELF-SEALING WATER TRAP/ADULT/PAEDIATRIC CIRCUITS	Mar 19, 1986	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K853665	SPLASH ADAPTOR	Oct 10, 1985	Substantially Equivalent	Ohio Medical Research, Inc.
K834573	AQUA TRAP	Mar 05, 1984	Substantially Equivalent	Airlife, Inc.
K820936	MOISTURE TRAP	Apr 29, 1982	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K812569	SHERWOOD WATER TRAP	Sep 25, 1981	Substantially Equivalent	Sherwood Medical Co.
K800990	TRACH MIST UNIT W/OR WITHOUT ELBOW	May 08, 1980	Substantially Equivalent	Airlife, Inc.
K792390	MOISTURE TRAP	Dec 04, 1979	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K790929	DRAINAGE BAG	May 21, 1979	Substantially Equivalent	Mem Medical, Inc.
K770771	AEROSOL EFFUSION SYSTEM #1740	Jun 02, 1977	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.