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Maxcess Needle Free Connector (8200)

by Solopak Medical Products, Inc.

510(k) K960661

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960661 Date21 Mar 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Maxcess Needle-Free Connector (8200) is a sterile, needle-free injection port designed for secure fluid transfer in intravenous and infusion systems. It features a one-piece Luer interface, eliminating the need for traditional needle connections while maintaining compatibility with existing medical tubing and devices.

Supplied in a Tyvek/polyethylene form-fill-seal package, the connector is intended for single-use in hospital settings. It adheres to FDA 510(k) clearance (K960661) under the product code FPA, classified under 21 CFR 880.5440, and is intended for general hospital use. The device is non-pyrogenic and packaged to ensure sterility before use.

Other devices from Solopak Medical Products, Inc.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Maxcess Needle-Free Connector (8200) used for?

    The Maxcess Needle-Free Connector (8200) is designed for secure fluid transfer in intravenous (IV) and infusion systems. Its one-piece Luer interface eliminates the need for traditional needle connections, reducing the risk of needle-stick injuries while maintaining compatibility with standard medical tubing and devices. This makes it ideal for hospital settings where safe and efficient fluid administration is critical.

  • How is the Maxcess Needle-Free Connector (8200) supplied and packaged?

    The connector is supplied in a sterile, form-fill-seal package made of Tyvek and polyethylene. This packaging ensures sterility before use and is intended for single-use only, adhering to hospital infection control protocols. The sealed packaging also protects the device from contamination during storage and transport.

  • Is the Maxcess Needle-Free Connector (8200) reusable or single-use?

    The Maxcess Needle-Free Connector (8200) is explicitly designed for single-use in hospital settings. This design choice minimizes the risk of cross-contamination and infection, aligning with clinical best practices for medical devices used in patient care.

  • What regulatory approval does the Maxcess Needle-Free Connector (8200) hold?

    The device holds FDA 510(k) clearance under the product code FPA, classified under 21 CFR 880.5440. It was determined to be substantially equivalent to a legally marketed predicate device and is intended for general hospital use. The clearance number is K960661.

  • Does the Maxcess Needle-Free Connector (8200) require special storage conditions?

    The connector should be stored in its original, unopened Tyvek/polyethylene package to maintain sterility. It should be kept in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. Proper storage ensures the device remains functional and safe for its intended single-use application.