Product code LDR— General Hospital
DEKA Infusion System, DEKA Administration Set
- Classification name
- Controller, Infusion, Intravascular, Electronic
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Total cleared
- 60
- First cleared
- Most recent
Market context for product code LDR
FDA has cleared devices under product code LDR between 1976 and 2024, filed by 38 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2024
- 2016
- 1997
- 1994
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
- 1983
- 1982
- 1981
Top applicants under product code LDR
Recent clearances under product code LDR
- K242693 — DEKA Infusion System, DEKA Administration Set
- K232316 — DEKA Infusion System, DEKA Administration Set
- K153760 — Volumetric Infusion Controller
- K963136 — PACER MODEL 100 INFUSION CONTROLLER
- K971826 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500
- K971865 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P
- K934543 — UNIVERSAL CONTROLLER, MODEL 100
- K935236 — FLOW CONTROLLING EXTENSION SET
- K905497 — MASTER FLOW I.V. PUMPETTE
- K905498 — STAT 2 IV PUMPETTE
- K896907 — 3M IV FLOW REGULATOR
- K894111 — VARI-SET
- K894487 — IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+
- K893487 — LIFECARE 75 CONTROLLER
- K884307 — IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262
- K882167 — IVY COMMANDER, MODEL 600
- K880006 — STA-SET I.V. FLOW REGULATOR
- K874481 — IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290
- K874916 — TECHNICON CHEM 1(TM) SYSTEM
- K874491 — IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+
- K870820 — IVY COMMANDER (MODEL 500)
- K870317 — IVAC (R) SITE-SAVER (TM) VOLUMETRIC CONTROLLER 280
- K870132 — IVAC FLOW CONTROL ADMINISTRATION SET
- K864789 — BETAFLO 2000 PIGGYBACK SYSTEM
- K864229 — STA-SET MODEL 250 I.V. FLOW REGULATOR
- K863204 — DEKA JR.
- K862273 — BETAFLO 2000
- K854863 — FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER
- K855000 — RATEMINDER III INFUSION DEVICE
- K851058 — DOSI FLOW
- K842209 — ARM-A-FLOW INTRAVENOUS FLOW REGULATOR
- K843254 — DK*300 VOLUMETRIC INFUSION CONTROLLER
- K842419 — IVAC 280 VOLUMETRIC INFUSION CONTROLLER
- K842210 — IVENT 302VC DUAL CONTROLLER
- K841318 — A.S.A.P.
- K842080 — ABBOTT LIFECARE 1050 CONTROLLER
- K834106 — INTRAVENOUS INFUSION CONTROLLER
- K840942 — IVY COMMANDEER
- K840644 — FLO-GARD 4000 VOLUMETRIC INFUSION
- K840823 — TREONIC C30
- K834528 — MODEL 2001 INTELLIGENT INFUSOR
- K834154 — FLO-GARD 8000 COMPUTER CONTROL INFUSI
- K833953 — ELECTRONIC GRAVITY 300VC
- K832739 — STEDIFLO INFUSION SET
- K833520 — RATEMINDER II SPECIALTY CARE
- K833682 — PRIMARY PIGGYBACK INFUSION SET W/PERM
- K832702 — POCKET AID
- K830780 — KOALA C99 I.V. CONTROLLER
- K823404 — VOLUMERIC CONTROLLER
- K822891 — FLO CONTROL
- K823026 — 380 PIGGYBACK CONTROLLER
- K822603 — PERMA-SET INFUSION SET
- K821579 — SKIN SCRUB-TRAY
- K812510 — TRAVENOL INFUSION CONTROLLER 2M8052
- K812233 — RATEMINDER
- K812114 — LIFECARE 1000 CONTROLLER
- K811432 — MILLIPORE DUAL RATE INTRAVENOUS CASSETTE
- K801861 — IVAC 260 SERIES VOLUME TRIC INFUSION CON
- K771158 — ID BRACLETS, ADULT & INFANT
- K760491 — TUMBLER, GENERAL MEDICAL MEDI-PAK
Data sourced from openFDA. This site is unofficial and independent of the FDA.