Data / Medical devices / I.V. Start Kit

I.V. Start Kit (LRS): 43 FDA-registered makers in 8 countries

43 establishments in 8 countries are registered with the FDA to make I.V. Start Kit (product code LRS, Class 2, 21 CFR 880.5200). 4 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 30 510(k) clearances under this code, the latest on May 2, 2005, and lists 45 recall events (3 Class I). FDA data exported November 2, 2026.

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Product code

LRS

Device class

2

Regulation

880.5200

Medical specialty

General Hospital

Makers by country

Makers of I.V. Start Kit

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated May 2, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.