LDR · Class II · 21 CFR 880.5725

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

Leading manufacturers include Y, Travenol Laboratories, S.A. and Abbott Laboratories.

60
Total
60
Cleared
83d
Avg days
1976
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 28d recently vs 84d historically

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 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 Feb 26, 1990
3M IV FLOW REGULATOR
K896907
3M Company
General Hospital · 80d
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 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 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 12, 1986
FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER
K854863
Travenol Laboratories, S.A.
General Hospital · 69d
Cleared Feb 12, 1986
RATEMINDER III INFUSION DEVICE
K855000
American Edwards Laboratories
General Hospital · 61d
Cleared Aug 07, 1984
IVAC 280 VOLUMETRIC INFUSION CONTROLLER
K842419
Y
General Hospital · 48d
Cleared Jul 18, 1984
A.S.A.P.
K841318
Trimedyne, Inc.
General Hospital · 107d
Cleared Jul 18, 1984
ABBOTT LIFECARE 1050 CONTROLLER
K842080
Abbott Laboratories
General Hospital · 56d
Cleared May 30, 1984
INTRAVENOUS INFUSION CONTROLLER
K834106
Cutter Laboratories, Inc.
General Hospital · 183d
Cleared Mar 23, 1984
FLO-GARD 4000 VOLUMETRIC INFUSION
K840644
Travenol Laboratories, S.A.
General Hospital · 37d
Cleared Feb 21, 1984
MODEL 2001 INTELLIGENT INFUSOR
K834528
Quest Medical, Inc.
General Hospital · 62d
Cleared Jan 25, 1984
FLO-GARD 8000 COMPUTER CONTROL INFUSI
K834154
Travenol Laboratories, S.A.
General Hospital · 54d
Cleared Dec 22, 1982
VOLUMERIC CONTROLLER
K823404
Quest Medical, Inc.
General Hospital · 37d
Cleared Nov 22, 1982
380 PIGGYBACK CONTROLLER
K823026
Imed Corp.
General Hospital · 39d

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 remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - LDR Product Code

Recent submissions under LDR have taken an average of 28 days to reach a decision - down from 84 days historically, suggesting improved FDA processing for this classification.

LDR devices are reviewed by the General Hospital panel. Browse all General Hospital devices →