Product Code: KZD FDA class 1 21 CFR 880.5420

Infusor, Pressure, For I.V. Bags

General Hospital

The Pressure Infusor for IV Bags is a device that applies external pressure to an intravenous fluid bag to increase the rate of fluid or blood product delivery into a patient, used in emergency medicine and surgical settings where rapid fluid resuscitation is required. 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 KZD, regulated under 21 CFR 880.5420, in the General Hospital medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: KZD
Device Class: FDA class 1
Regulation Number: 880.5420
Medical Specialty: General Hospital
Review Panel: HO
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 35 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K974074	INFUSION DYNAMICS POWER INFUSER	Feb 17, 1998	Substantially Equivalent	Infusion Dynamics, Inc.
K973843	MSI PRESSURE INFUSOR	Oct 29, 1997	Substantially Equivalent	Smith Assoc.
K953290	OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP	Oct 07, 1995	Substantially Equivalent	Olympus America, Inc.
K951988	PRESSURIZER	Jun 14, 1995	Substantially Equivalent	Promedic, Inc.
K942933	PRESSURE INFUSION CUFF	Aug 25, 1994	Substantially Equivalent	Circulatory Technology, Inc.
K930012	KAWASUMI LABORATORIES K-CUFF	Dec 14, 1993	Substantially Equivalent	Kawasumi Laboratories Co., Ltd.
K921168	ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000	Apr 21, 1993	Substantially Equivalent	Allen Medical Systems, Inc.
K913751	PRESSURE INFUSER	Jan 09, 1992	Substantially Equivalent	Biomedical Dynamics, Inc.
K910926	TECNADYNE SURGI-SQUEEZE INFUSION PUMP	Aug 02, 1991	Substantially Equivalent	Tecnadyne Scientific, Inc.
K911216	INFUSABLE	Jul 22, 1991	Substantially Equivalent	Biomedical Dynamics, Inc.
K904484	BAXTER SINGLE PATIENT USE PRESSURE INFUSOR	Oct 26, 1990	Substantially Equivalent	Tecnadyne Scientific, Inc.
K901225	LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR)	Aug 23, 1990	Substantially Equivalent	Abbott Laboratories
K894927	SURGI SQUEEZ	Sep 11, 1989	Substantially Equivalent	Ethox Corp.
K881977	PRESSURE INFUSOR	Jul 29, 1988	Substantially Equivalent	Primrose Medical, Inc.
K874454	IV-PUSH, CONSTANT INFUSION PUMP	Nov 06, 1987	Substantially Equivalent	Medical Products Search, Inc.
K861977	BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR	Jul 15, 1986	Substantially Equivalent	Biomedical Dynamics, Inc.
K854807	LIFE PAC	Apr 15, 1986	Substantially Equivalent	Lifemed Technologies, Inc.
K860084	PRESSURE INFUSOR #1900	Mar 18, 1986	Substantially Equivalent	Pa Medical Corp.
K855054	THE WOOD PUMP 'OLE RED'	Mar 18, 1986	Substantially Equivalent	T.C. Retigo, Inc.
K851904	DATA TRAC ANESTHESIOLOGY RECORDER	May 10, 1985	Substantially Equivalent	Datascope Corp.
K832377	BIOCUFF INFUSION BAG PRESSOR	Aug 12, 1983	Substantially Equivalent	Bio-Medical Instruments , Ltd.
K822434	CREST PRESSURE INFUSOR	Sep 17, 1982	Substantially Equivalent	Crest Medical Equipment
K822286	AUTOCUFF (PHOTOS ENCLOSED WITH 510K	Aug 27, 1982	Substantially Equivalent	Partamed, Inc.
K820159	PRESSURE INFUSER	Apr 21, 1982	Substantially Equivalent	David Clark Company, Inc.
K813105	PRESSURE INFUSION PUMP	Dec 14, 1981	Substantially Equivalent	Calbio, Inc.
K810954	NORFOLK/NORWICH PRESSURE INFUSION BOX	Apr 21, 1981	Substantially Equivalent	Medical Innovations Corp.
K800560	MX820-5 PRESSURE INFUSOR 500CC MX820-10	Apr 29, 1980	Substantially Equivalent	Medex, Inc.
K781037	PRESSURE INFUSION DEVICE	Sep 14, 1978	Substantially Equivalent	Hinck Medical, Inc.
K780465	VOLUME CONTROL DEVICE VCD-150	Jun 02, 1978	Substantially Equivalent	Sorensen Research
K771458	INFUSION ACCELERATOR	Aug 26, 1977	Substantially Equivalent	Terumo America, Inc.
K770758	INJECTION SYSTEM, MDC I.V.	May 20, 1977	Substantially Equivalent	Medical Development Co.
K760895	AUTOMATIC SHUT-OFF VALVE	Dec 09, 1976	Substantially Equivalent	Delta Medical Industries
K760505	SOLUTION ADMINISTRATION SET (#2C0631)	Sep 03, 1976	Substantially Equivalent	Travenol Laboratories, S.A.
K760483	BLOOD-SOLUTION ADMINISTRATION SET, SURG.	Sep 03, 1976	Substantially Equivalent	Travenol Laboratories, S.A.
K760313	KIT, PREP, INSPIRON IV	Aug 04, 1976	Substantially Equivalent	Inspiron Corp.