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Check Valve Solution Set

FDA 510(k)

Class II (US FDA 510(k))

510(k) K941453

by Douglas Medical Products Corp.

Identifiers

510(k) Number
K941453 FDA 510(k)
FDA Product Code
FPA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5440 FDA 510(k)
Regulation Number
880.5440 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Check Valve Solution Set is a medical device designed to facilitate the administration of intravenous solutions. It incorporates a check valve mechanism to regulate fluid flow and prevent backflow during clinical use.

This device is supplied by Douglas Medical Products Corp. and has received FDA 510(k) clearance. It is intended for use within general hospital settings as part of an administration set.

Frequently asked questions

What is the primary function of the Check Valve Solution Set?

This device is designed to facilitate the administration of intravenous solutions. It features an integrated check valve mechanism that regulates fluid flow and prevents backflow to ensure consistent delivery during clinical procedures.

In what clinical environments is this device intended for use?

The Check Valve Solution Set is intended for use within general hospital settings. It is designed to function as a component of an intravenous administration set to support standard fluid therapy requirements.

What is the regulatory status of this device?

The Check Valve Solution Set manufactured by Douglas Medical Products Corp. has received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

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: CHECK VALVE SOLUTION SET (K941453) — FDA 510 (k) | Innolitics, K941453 FDA 510 (k) - CHECK VALVE SOLUTION SET, PDF K941453 CHECK VALVE SOLUTION SET - 510kdatabase.net, Douglas Medical Products | US Medical Device company registered with ..., DOUGLAS MEDICAL PRODUCTS, INC - fda.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Douglas Medical Products Corp.

Sources (1)

  • FDA 510(k) K941453 24 fields · synced Sep 24, 2026