Micro Infusion Set

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K833949 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Cadd-Vt, 5300 Ambulatory Infusion Pump W/3050, 50M

  Class II

  FDA 510(k) K850183 Active Cleared 13 Mar 1985

• Cadd-1, Model 5100 Hf, Ambulatory Infusion Pump

  Class II

  FDA 510(k) K853584 Active Cleared 12 Nov 1985

• Ac Adapter Accessory, Product Code 600123A

  Class II

  FDA 510(k) K870768 Active Cleared 13 Mar 1987

• Cadd-1, Model 5100 Hf

  Class II

  FDA 510(k) K862927 Active Cleared 27 Aug 1986

• Pharmacia Deltec Subclavian Introducers

  Class II

  FDA 510(k) K871132 Active Cleared 20 Apr 1987

• CADD-1 5100 Ambulatory Infusion Pump

  Class II

  FDA 510(k) K843772 Active Cleared 6 Dec 1984

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• What clinical purpose does the Micro Infusion Set serve?

  The Micro Infusion Set is intended to provide controlled delivery of fluids or medications through a small‑bore catheter system, allowing precise infusion rates for patients who require accurate dosing, such as in intravenous therapy or medication administration.

• How is the Micro Infusion Set packaged and supplied to users?

  The device is supplied as a complete set that includes the catheter and associated tubing, ready for immediate clinical use. Packaging is designed to maintain sterility until the point of opening, ensuring the system remains uncontaminated during storage and transport.

• Is the Micro Infusion Set sterile and intended for single‑use only?

  Yes, the Micro Infusion Set is provided sterile and is intended for single‑use application. Single‑use design prevents cross‑contamination and maintains the integrity of the infusion pathway, which is critical for patient safety.

• What sizes or model variations are available for the Micro Infusion Set?

  The available data do not specify multiple sizes or model numbers; the product is identified simply as the Micro Infusion Set under product code FPA. Clinicians should refer to the manufacturer’s catalog for any size options that may exist.

• Through which regulatory pathway was the Micro Infusion Set cleared?

  The device received traditional FDA 510(k) clearance (K833949) on 11 January 1984 after being found substantially equivalent to a predicate device, following the standard review process for Class II medical devices.