Low Volume Infustion Set

FDA 510(k) K821624 · Lifemed of California

Substantially Equivalent

510(k) numberK821624

Submission

Device name
Low Volume Infustion Set
Applicant
Lifemed of California
Mchenry, IL, US
Received
June 2, 1982
Decision date
June 22, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FPA – Set, Administration, Intravascular
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

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K250325BD Alaris Pump Infusion SetFPA · Traditional Carefusion (Bd)10/30/2025SE
K251814EZ™ IV Administration SetFPA · Traditional Epic Medical Pte. , Ltd.08/29/2025SE
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More from B.Braun Medical, Inc.

510(k)DeviceDecision
K001329Intravascular IV Set, IV Set with Burette, Extension SetFPA · Traditional 02/14/2001SE
K903502Lifecoil CatheterFJS · Traditional 10/22/1990SE
K841929Lifemed Lifecoil CathetersFKX · Traditional 08/08/1984SE

Questions and answers

When was Low Volume Infustion Set cleared by the FDA?

Low Volume Infustion Set (K821624) received a 510(k) decision of Substantially Equivalent on June 22, 1982, 20 days after the submission was received.

What is the product code of K821624?

The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.