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

I.V. Start Kit

21 CFR 880.5200 / General Hospital
FDA source (opens on fda.gov)

LRS is the FDA product code for I.V. Start Kit, a class II device type, regulated under 21 CFR 880.5200. FDA's definition for this code reads: "This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above...". As of , FDA records hold 30 510(k) clearances under this code, the most recent dated , and 164 recalls.

Classification record

Product code
LRS
Device name
I.V. Start Kit
FDA definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
30
Ingested recalls
165

Clearances, product code LRS

By decision year
30 clearances under product code LRS with a decision year between 1976 and 2005, 1993 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code LRS by decision year
YearClearances
19761
19821
19842
19851
19862
19872
19881
19921
19939
19945
19952
19961
20011
20051

Applicants with the most clearances

Product code LRS
Applicants holding the most 510(k) clearances under product code LRS
ApplicantClearances
Customed, Inc2
American Biomaterials Corp.1
Amsino International, Inc.1
B. Braun of America, Inc.1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Becton Dickinson Vascular Access, Inc.1
Brigam Medical, Inc.1
Busse Hospital Disposables1
Clinical Resources, Inc.1
Cml, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 54 companies shown, in name order