510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LDRClass II

Controller, Infusion, Intravascular, Electronic

21 CFR 880.5725 / General Hospital
FDA source (opens on fda.gov)

LDR is the FDA product code for Controller, Infusion, Intravascular, Electronic, a class II device type, regulated under 21 CFR 880.5725. As of , FDA records hold 60 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
LDR
Device name
Controller, Infusion, Intravascular, Electronic
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
60
Ingested recalls
5

Clearances, product code LDR

By decision year
60 clearances under product code LDR with a decision year between 1976 and 2024, 1984 the highest year at 12.
Show the numbers
510(k) clearances under FDA product code LDR by decision year
YearClearances
19761
19771
19801
19814
19825
19836
198412
19851
19865
19873
19887
19893
19901
19912
19942
19973
20161
20242

Applicants with the most clearances

Product code LDR
Applicants holding the most 510(k) clearances under product code LDR
ApplicantClearances
Y6
Deka Research & Development Corp.5
Travenol Laboratories, S.A.4
Abbott Medical3
Ivy Medical, Inc.3
Alexander Mfg. Co.2
Anatros Corp.2
Betaflo, Inc.2
Cosmetic Sciences, Inc.2
Quest Medical, Inc2

Companies listing this code with FDA

Companies whose registered establishments list this code