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T-Connectors 014500/014501/014502/014503-120

by Clinical Connections, Inc.

510(k) K870912

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK870912 Date17 Mar 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
FPK
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 T-Connectors 014500/014501/014502/014503-120 are classified as Tubing, Fluid Delivery, designed to facilitate the connection and transition of fluid pathways in medical applications. These connectors feature a T-shaped junction, enabling the merging of two fluid lines into one or splitting a single line into multiple outlets, ensuring secure and leak-free fluid transfer in clinical settings.

These connectors are intended for single-use in general hospital environments and are supplied sterile. They are classified as Class II devices under FDA regulation 880.5440 and have received FDA 510(k) clearance (K870912) as substantially equivalent to a predicate device. The connectors are not intended for MRI use and must be stored in a clean, dry environment to maintain sterility and functionality.

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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 are the T-Connectors 014500/014501/014502/014503-120 designed for?

    These T-Connectors are designed to facilitate the connection and transition of fluid pathways in medical applications. Their T-shaped junction allows for merging two fluid lines into one or splitting a single line into multiple outlets, ensuring secure and leak-free fluid transfer in clinical settings like general hospitals.

  • Are the T-Connectors 014500/014501/014502/014503-120 intended for reuse?

    No, these T-Connectors are explicitly intended for single-use only. This design ensures patient safety and sterility, as reuse could compromise the integrity of the connector and introduce contamination risks.

  • How should the T-Connectors 014500/014501/014502/014503-120 be stored to maintain sterility?

    The connectors must be stored in a clean, dry environment to preserve sterility and functionality. Avoid exposure to moisture, dust, or direct sunlight, as these conditions can degrade the material or compromise the sterile packaging.

  • Can these T-Connectors be used in MRI environments?

    No, the T-Connectors 014500/014501/014502/014503-120 are explicitly not intended for MRI use. This restriction is likely due to potential material compatibility issues or electromagnetic interference concerns in magnetic resonance imaging settings.

  • What regulatory classification and clearance do these T-Connectors hold?

    These T-Connectors are classified as Class II medical devices under FDA regulation 21 CFR 880.5440 and have received FDA 510(k) clearance (K870912) as substantially equivalent to a predicate device. The clearance was granted under the Traditional 510(k) review pathway by the FDA’s Orthopaedic Devices Panel (HO).