Product Code: KDP FDA class 2 21 CFR 880.6740

Regulator, Vacuum

General Hospital

A vacuum regulator is a device used in hospital settings to control and maintain the level of negative pressure (suction) delivered to a patient or clinical application from a central vacuum system, used for wound drainage, airway suctioning, or fluid aspiration. It is classified as an FDA Class 2 device, indicating moderate risk, and requires premarket clearance or a 510(k) submission. Product code KDP is regulated under 21 CFR 880.6740 in the General Hospital medical specialty. No additional special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: KDP
Device Class: FDA class 2
Regulation Number: 880.6740
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

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 21 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K013976	BOEHRINGER MRI SUCTION REGULATORY	Jan 08, 2002	Substantially Equivalent	Boehringer Laboratories
K944479	PM3300 INTERMITTENT VACUUM	Dec 22, 1994	Substantially Equivalent	Precision Medical, Inc.
K942747	MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) )	Jul 21, 1994	Substantially Equivalent	Engineered Orthopedic Technologies, Inc.
K933232	BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED	Mar 28, 1994	Substantially Equivalent	Boehringer Laboratories
K926140	VACUUM POWER BODY FLUID SUCTION APPARATUS	Jul 27, 1993	Substantially Equivalent	Hill-Rom, Inc.
K922817	PM3000 & PM3100 VACUUM REGULATOR	Mar 04, 1993	Substantially Equivalent	Precision Medical, Inc.
K883229	OHMEDA CONTINUOUS SUCTION REGULATOR	Oct 19, 1988	Substantially Equivalent	Ohmeda Medical
K875074	VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000	Feb 22, 1988	Substantially Equivalent	Timeter Instrument Corp.
K853155	BOEHRINGER LAB SUCTION INTERRUPTER	Oct 16, 1985	Substantially Equivalent	Boehringer Laboratories
K850200	SUCTION REGULATOR 7700 SERIES	Mar 04, 1985	Substantially Equivalent	Boehringer Laboratories
K843591	INTERCEPT	Oct 19, 1984	Substantially Equivalent	Vital Signs, Inc.
K834224	VACUUM REGULATOR 0-2000 MMHG VR-1000	Feb 27, 1984	Substantially Equivalent	Trimeter Instrument Corp.
K831505	THORACIC GAUGE #TG-60 -VACUUM REGULATOR	Jul 12, 1983	Substantially Equivalent	Sorensen Research
K830343	CONTAINER W/PRIMING SOLUTION	Mar 17, 1983	Substantially Equivalent	American Hospital Supply Corp.
K821314	FEVER METER	May 28, 1982	Substantially Equivalent	Steridyne Corp.
K820706	WATERLESS SEAL & VACUUM REGULATOR	Apr 09, 1982	Substantially Equivalent	Sorensen Research
K820077	EMERSON THORACIC SUCTION REG. #55-JP	Jan 28, 1982	Substantially Equivalent	J. H. Emerson Co.
K801169	OHIO FREE FLOW VACUUM REGULATOR	Jul 28, 1980	Substantially Equivalent	Ohio Medical Products
K770944	INSTATEMP	Jul 27, 1977	Substantially Equivalent	H.I. Silverman, D.Sc.
K760317	REGULATORS, HIGH SUCTION	Aug 04, 1976	Substantially Equivalent	Harris-Lake, Inc.
K760316	REGULATORS, LOW SUCTION	Aug 04, 1976	Substantially Equivalent	Harris-Lake, Inc.