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Pocket Aid Controller, Infusion, Intravascular, Electronic

FDA 510(k)

Class II (US FDA 510(k))

510(k) K832702

by M.c. Johnson Co., Inc.

Identifiers

510(k) Number
K832702 FDA 510(k)
FDA Product Code
LDR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5725 FDA 510(k)
Regulation Number
880.5725 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Pocket Aid is a Controller, Infusion, Intravascular, Electronic device, classified as a Class II medical device under FDA regulations. It is designed to regulate and control the delivery of intravenous fluids or medications, ensuring precise dosing and flow rates for patient treatment in clinical settings.

This device is intended for single-use in general hospital environments and has received FDA 510(k) clearance under the traditional review pathway. Supplied as a sterile, disposable unit, it operates under standard hospital conditions and adheres to regulatory standards outlined in 21 CFR 880.5725. No MRI safety or reusable specifications are indicated in the available data.

Frequently asked questions

What clinical setting is the Pocket Aid designed for and how does it function in that environment?

The Pocket Aid is specifically designed for use in general hospital environments, where it regulates and controls the delivery of intravenous fluids or medications. It ensures precise dosing and flow rates, making it suitable for administering treatments where accurate infusion control is critical, such as in patient care areas like wards, emergency rooms, or procedural suites. Its single-use, disposable nature aligns with standard hospital protocols for infection control and workflow efficiency.

Is the Pocket Aid reusable, or is it intended for single-use only? How does this affect its sterility and handling?

The Pocket Aid is intended for single-use only, as explicitly stated in its design specifications. This means each unit is sterile upon packaging and must not be reused after a single patient treatment. The disposable nature ensures sterility is maintained without requiring reprocessing, reducing the risk of contamination and simplifying compliance with hospital infection control protocols.

What are the key specifications or features that distinguish the Pocket Aid from other infusion controllers?

The Pocket Aid is classified as a Class II electronic infusion controller under FDA regulations (21 CFR 880.5725) and is substantially equivalent to predicate devices, meaning it meets established safety and performance standards. It operates under standard hospital conditions, ensuring compatibility with typical clinical environments. Unlike some infusion devices, it lacks MRI safety specifications, so it should not be used in MRI-compatible settings unless explicitly verified otherwise.

How was the Pocket Aid’s regulatory approval process determined, and what does that mean for its use?

The Pocket Aid received FDA 510(k) clearance through the traditional review pathway, meaning its safety and effectiveness were evaluated by the FDA against predicate devices already on the market. This approval route confirms the device complies with regulatory standards for infusion controllers in general hospitals. Clinicians and buyers can rely on this clearance to ensure the device meets established performance criteria for intravenous fluid or medication delivery.

Are there specific storage requirements for the Pocket Aid, or can it be stored under standard hospital conditions?

The Pocket Aid is supplied as a sterile, disposable unit and is designed for use under standard hospital conditions, implying no specialized storage beyond typical clinical environments. However, as with all sterile medical devices, it should be stored in a clean, dry place away from direct sunlight or extreme temperatures to preserve its integrity until use. Always follow manufacturer guidelines for unopened packaging to ensure sterility is maintained.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: POCKET AID (K832702) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
M.c. Johnson Co., Inc.

Sources (1)

  • FDA 510(k) K832702 24 fields · synced Sep 19, 2026