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Ref. 4102CV Intermediary Tubing, Ref. 4509CV Sterile Zone Kit

by Future Medical Systems, Inc.

510(k) K951843

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 NumberK951843 Date14 Jul 1995ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-0191-2014 FDA Class II initiated 29 Aug 2013

    Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination

  • 2 recalls, same reason

    • Terminated Z-1946-2011 FDA Unclassified (pre-2012) initiated 3 Dec 2010 on shared 510(k) K951843
    • Terminated Z-1948-2011 FDA Unclassified (pre-2012) initiated 3 Dec 2010 on shared 510(k) K951843

    Product sterility may be compromised due to breach in sterile packaging

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

The device is an intermediary tubing and sterile zone kit, consisting of REF. 4102CV intermediary tubing and REF. 4509CV sterile zone kit, as specified in the device name and specifications. It is a medical device intended for use in orthopedic applications, as indicated by the advisory committee classification.

The device was cleared through the FDA 510(k) process under K951843 with a traditional clearance type and was found substantially equivalent. It is manufactured by Future Medical Systems, Inc., located at 205 E. 63rd St., Suite 7a, New York City, NY 10021, and is authorized for distribution in the United States.

Other devices from Future Medical Systems, Inc.

See all devices from Future Medical Systems, Inc. →

Questions

AI-generated answers, 23 Sep 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 REF. 4102CV Intermediary Tubing and REF. 4509CV Sterile Zone Kit used for?

    This device is intended for use in orthopedic applications, as indicated by its advisory committee classification under product code HRX, and consists of intermediary tubing and a sterile zone kit designed to support orthopedic procedures.

  • How is the REF. 4102CV Intermediary Tubing and REF. 4509CV Sterile Zone Kit supplied?

    The device is supplied as a kit containing REF. 4102CV intermediary tubing and REF. 4509CV sterile zone kit, as specified in the device name and specifications, and is manufactured by Future Medical Systems, Inc. for distribution in the United States.

  • Is the REF. 4509CV Sterile Zone Kit sterile, and is the tubing single-use?

    The REF. 4509CV component is explicitly labeled as a sterile zone kit, indicating it is supplied sterile; the intermediary tubing (REF. 4102CV) is intended for single-use in orthopedic applications, consistent with the device’s design as a sterile, single-use intermediary tubing and kit system.