LDR · Class II · 21 CFR 880.5725

FDA Product Code LDR: Controller, Infusion, Intravascular, Electronic

Leading manufacturers include Y, Travenol Laboratories, S.A. and Ivy Medical, Inc..

60
Total
60
Cleared
83d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Controller, Infusion, Intravascular, Electronic Devices (Product Code LDR)

60 devices
1–24 of 60
Cleared Oct 07, 2024
DEKA Infusion System, DEKA Administration Set
K242693
Deka Research and Development Corporation
General Hospital · 28d
Cleared Mar 01, 2024
DEKA Infusion System, DEKA Administration Set
K232316
Deka Research and Development
General Hospital · 211d
Cleared Oct 03, 2016
Volumetric Infusion Controller
K153760
DEKA Research & Development
General Hospital · 278d
Cleared Oct 10, 1997
PACER MODEL 100 INFUSION CONTROLLER
K963136
Health Watch, Inc.
General Hospital · 423d
Cleared Jul 03, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500
K971826
Alexander Mfg. Co.
General Hospital · 48d
Cleared Jul 03, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P
K971865
Alexander Mfg. Co.
General Hospital · 44d
Cleared Mar 29, 1994
UNIVERSAL CONTROLLER, MODEL 100
K934543
Metamed, Inc.
General Hospital · 194d
Cleared Feb 24, 1994
FLOW CONTROLLING EXTENSION SET
K935236
Block Medical, Inc.
General Hospital · 115d
Cleared Apr 16, 1991
MASTER FLOW I.V. PUMPETTE
K905497
The Master Medical Corp.
General Hospital · 130d
Cleared Apr 16, 1991
STAT 2 IV PUMPETTE
K905498
The Master Medical Corp.
General Hospital · 130d
Cleared Feb 26, 1990
3M IV FLOW REGULATOR
K896907
3M Company
General Hospital · 80d
Cleared Sep 28, 1989
VARI-SET
K894111
Sonex Medical
General Hospital · 108d
Cleared Sep 27, 1989
IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+
K894487
Y
General Hospital · 71d
Cleared Jul 28, 1989
LIFECARE 75 CONTROLLER
K893487
Abbott Laboratories
General Hospital · 85d
Cleared Nov 01, 1988
IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262
K884307
Y
General Hospital · 19d
Cleared Sep 23, 1988
IVY COMMANDER, MODEL 600
K882167
Ivy Medical, Inc.
General Hospital · 122d
Cleared Mar 24, 1988
STA-SET I.V. FLOW REGULATOR
K880006
Controlled Flow , Ltd.
General Hospital · 80d
Cleared Mar 03, 1988
IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290
K874481
Y
General Hospital · 122d
Cleared Mar 03, 1988
TECHNICON CHEM 1(TM) SYSTEM
K874916
Technicon Instruments Corp.
Chemistry · 91d
Cleared Feb 25, 1988
IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+
K874491
Y
General Hospital · 115d
Cleared Jan 20, 1988
IVY COMMANDER (MODEL 500)
K870820
Ivy Medical, Inc.
General Hospital · 323d
Cleared Apr 03, 1987
IVAC (R) SITE-SAVER (TM) VOLUMETRIC CONTROLLER 280
K870317
Y
General Hospital · 65d
Cleared Feb 05, 1987
IVAC FLOW CONTROL ADMINISTRATION SET
K870132
Y
General Hospital · 24d
Cleared Feb 04, 1987
BETAFLO 2000 PIGGYBACK SYSTEM
K864789
Betaflo, Inc.
General Hospital · 58d

About Product Code LDR - Regulatory Context

510(k) Submission Activity

60 total 510(k) submissions under product code LDR since 1976, with 60 receiving FDA clearance (average review time: 83 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.