Product Code: LDR FDA class 2 21 CFR 880.5725

Controller, Infusion, Intravascular, Electronic

General Hospital

An electronic intravascular infusion controller is a general hospital device that uses electronic control mechanisms to regulate the flow rate of intravenous fluids administered to patients, providing more precise delivery than gravity-based systems. It is classified as FDA Class 2, reflecting moderate risk and requiring 510(k) premarket clearance. The product code is LDR, regulated under 21 CFR 880.5725, in the General Hospital specialty. No special risk flags apply.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LDR
Device Class: FDA class 2
Regulation Number: 880.5725
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

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 60 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242693	DEKA Infusion System, DEKA Administration Set	Oct 07, 2024	Substantially Equivalent	Deka Research and Development Corporation
K232316	DEKA Infusion System, DEKA Administration Set	Mar 01, 2024	Substantially Equivalent	Deka Research and Development
K153760	Volumetric Infusion Controller	Oct 03, 2016	Substantially Equivalent	DEKA Research & Development
K963136	PACER MODEL 100 INFUSION CONTROLLER	Oct 10, 1997	Substantially Equivalent	Health Watch, Inc.
K971865	ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P	Jul 03, 1997	Substantially Equivalent	Alexander Mfg. Co.
K971826	ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500	Jul 03, 1997	Substantially Equivalent	Alexander Mfg. Co.
K934543	UNIVERSAL CONTROLLER, MODEL 100	Mar 29, 1994	Substantially Equivalent	Metamed, Inc.
K935236	FLOW CONTROLLING EXTENSION SET	Feb 24, 1994	Substantially Equivalent	Block Medical, Inc.
K905498	STAT 2 IV PUMPETTE	Apr 16, 1991	Substantially Equivalent	The Master Medical Corp.
K905497	MASTER FLOW I.V. PUMPETTE	Apr 16, 1991	Substantially Equivalent	The Master Medical Corp.
K896907	3M IV FLOW REGULATOR	Feb 26, 1990	Substantially Equivalent	3M Company
K894111	VARI-SET	Sep 28, 1989	Substantially Equivalent	Sonex Medical
K894487	IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+	Sep 27, 1989	Substantially Equivalent	Y
K893487	LIFECARE 75 CONTROLLER	Jul 28, 1989	Substantially Equivalent	Abbott Laboratories
K884307	IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262	Nov 01, 1988	Substantially Equivalent	Y
K882167	IVY COMMANDER, MODEL 600	Sep 23, 1988	Substantially Equivalent	Ivy Medical, Inc.
K880006	STA-SET I.V. FLOW REGULATOR	Mar 24, 1988	Substantially Equivalent	Controlled Flow , Ltd.
K874916	TECHNICON CHEM 1(TM) SYSTEM	Mar 03, 1988	Substantially Equivalent	Technicon Instruments Corp.
K874481	IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290	Mar 03, 1988	Substantially Equivalent	Y
K874491	IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+	Feb 25, 1988	Substantially Equivalent	Y
K870820	IVY COMMANDER (MODEL 500)	Jan 20, 1988	Substantially Equivalent	Ivy Medical, Inc.
K870317	IVAC (R) SITE-SAVER (TM) VOLUMETRIC CONTROLLER 280	Apr 03, 1987	Substantially Equivalent	Y
K870132	IVAC FLOW CONTROL ADMINISTRATION SET	Feb 05, 1987	Substantially Equivalent	Y
K864789	BETAFLO 2000 PIGGYBACK SYSTEM	Feb 04, 1987	Substantially Equivalent	Betaflo, Inc.
K864229	STA-SET MODEL 250 I.V. FLOW REGULATOR	Dec 16, 1986	Substantially Equivalent	Sta-Set Corp.
K863204	DEKA JR.	Sep 03, 1986	Substantially Equivalent	Deka Research & Development Corp.
K862273	BETAFLO 2000	Jul 18, 1986	Substantially Equivalent	Betaflo, Inc.
K855000	RATEMINDER III INFUSION DEVICE	Feb 12, 1986	Substantially Equivalent	American Edwards Laboratories
K854863	FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER	Feb 12, 1986	Substantially Equivalent	Travenol Laboratories, S.A.
K851058	DOSI FLOW	Apr 29, 1985	Substantially Equivalent	Leventon, S.A.
K842209	ARM-A-FLOW INTRAVENOUS FLOW REGULATOR	Dec 04, 1984	Substantially Equivalent	Armour Pharmaceutical Co.
K843254	DK*300 VOLUMETRIC INFUSION CONTROLLER	Oct 11, 1984	Substantially Equivalent	Deka Research & Development Corp.
K842419	IVAC 280 VOLUMETRIC INFUSION CONTROLLER	Aug 07, 1984	Substantially Equivalent	Y
K842210	IVENT 302VC DUAL CONTROLLER	Jul 25, 1984	Substantially Equivalent	Ivent Corp.
K842080	ABBOTT LIFECARE 1050 CONTROLLER	Jul 18, 1984	Substantially Equivalent	Abbott Laboratories
K841318	A.S.A.P.	Jul 18, 1984	Substantially Equivalent	Trimedyne, Inc.
K834106	INTRAVENOUS INFUSION CONTROLLER	May 30, 1984	Substantially Equivalent	Cutter Laboratories, Inc.
K840942	IVY COMMANDEER	Mar 30, 1984	Substantially Equivalent	Ivy Medical, Inc.
K840823	TREONIC C30	Mar 23, 1984	Substantially Equivalent	Vickers America Medical Corp.
K840644	FLO-GARD 4000 VOLUMETRIC INFUSION	Mar 23, 1984	Substantially Equivalent	Travenol Laboratories, S.A.
K834528	MODEL 2001 INTELLIGENT INFUSOR	Feb 21, 1984	Substantially Equivalent	Quest Medical, Inc.
K834154	FLO-GARD 8000 COMPUTER CONTROL INFUSI	Jan 25, 1984	Substantially Equivalent	Travenol Laboratories, S.A.
K833953	ELECTRONIC GRAVITY 300VC	Dec 29, 1983	Substantially Equivalent	Ivent Corp.
K833520	RATEMINDER II SPECIALTY CARE	Dec 22, 1983	Substantially Equivalent	Anatros Corp.
K832739	STEDIFLO INFUSION SET	Dec 22, 1983	Substantially Equivalent	Dravon Medical, Inc.
K833682	PRIMARY PIGGYBACK INFUSION SET W/PERM	Nov 28, 1983	Substantially Equivalent	Cosmetic Sciences, Inc.
K832702	POCKET AID	Nov 17, 1983	Substantially Equivalent	M.C. Johnson Co., Inc.
K830780	KOALA C99 I.V. CONTROLLER	Apr 08, 1983	Substantially Equivalent	Chesebrough-Pond'S U.S.A. Co.
K823404	VOLUMERIC CONTROLLER	Dec 22, 1982	Substantially Equivalent	Quest Medical, Inc.
K822891	FLO CONTROL	Nov 24, 1982	Substantially Equivalent	Dna Medical, Inc.
K823026	380 PIGGYBACK CONTROLLER	Nov 22, 1982	Substantially Equivalent	Imed Corp.
K822603	PERMA-SET INFUSION SET	Sep 14, 1982	Substantially Equivalent	Cosmetic Sciences, Inc.
K821579	SKIN SCRUB-TRAY	Jul 21, 1982	Substantially Equivalent	Associated Medical Products Co.
K812510	TRAVENOL INFUSION CONTROLLER 2M8052	Sep 16, 1981	Substantially Equivalent	Travenol Laboratories, S.A.
K812233	RATEMINDER	Aug 25, 1981	Substantially Equivalent	Anatros Corp.
K812114	LIFECARE 1000 CONTROLLER	Aug 20, 1981	Substantially Equivalent	Abbott Laboratories
K811432	MILLIPORE DUAL RATE INTRAVENOUS CASSETTE	Jul 13, 1981	Substantially Equivalent	Millipore Corp.
K801861	IVAC 260 SERIES VOLUME TRIC INFUSION CON	Aug 27, 1980	Substantially Equivalent	Y
K771158	ID BRACLETS, ADULT & INFANT	Oct 13, 1977	Substantially Equivalent	Divers-A-Med
K760491	TUMBLER, GENERAL MEDICAL MEDI-PAK	Sep 15, 1976	Substantially Equivalent	Landmark Plastics