Adr Thinset Infusion Set Model, 23-106, 23-109, 43-106, 43-109

Q: What is the product code of K033099?

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

FDA 510(k) K033099 · Applied Diabetes Research, Incorporated

Substantially Equivalent

510(k) numberK033099

Submission

Device name: Adr Thinset Infusion Set Model, 23-106, 23-109, 43-106, 43-109
Applicant: Applied Diabetes Research, Incorporated
Laguna Niguel, CA, US
Received: September 29, 2003
Decision date: October 16, 2003
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

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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K243392	Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional	B.Braun Medical, Inc.	07/24/2025SE

More from B.Braun Medical, Inc.

510(k)	Device	Decision
K041152	Thinset 1.8 ML Reservoir, Model 326A; Thinset 3.0 ML Reservoir, Model 332AFRN · Special	05/24/2004SE
K024056	Sureset 3.0 ML Reservoir, Model 24-103FRN · Traditional	01/17/2003SE
K012429	Sureset Infusion Set, Model 8023FPA · Traditional	11/06/2001SE

Questions and answers

When was Adr Thinset Infusion Set Model, 23-106, 23-109, 43-106, 43-109 cleared by the FDA?

Adr Thinset Infusion Set Model, 23-106, 23-109, 43-106, 43-109 (K033099) received a 510(k) decision of Substantially Equivalent on October 16, 2003, 17 days after the submission was received.

What is the product code of K033099?

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