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Precison Thermoplastic Components Gas Ampling Lines and Connectors

by Precision Thermoplastic Components, Inc.

510(k) K943874

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 NumberK943874 Date28 Oct 1994ClearedStatusActive

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  • Withdrawn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
CAH
Device Class
Class II
Regulation
21 CFR Part 868.5260
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Precision Thermoplastic Components Gas Sampling Lines and Connectors are medical devices used for gas sampling in breathing circuits. These components are designed to facilitate the collection and transport of gas samples for monitoring purposes during anesthesia procedures.

The device is supplied as a Class 2 medical device with FDA 510(k) clearance K943874, granted on October 28, 1994. It is manufactured by Precision Thermoplastic Components, Inc. and is intended for use in anesthesiology settings. The device is not specified as single-use or reusable, and no information regarding MRI safety or storage conditions is provided in the data.

Other devices from Precision Thermoplastic Components, Inc.

Questions

AI-generated answers, 27 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 purpose of these gas sampling lines and connectors?

    These components are used in anesthesia breathing circuits to collect and transport gas samples for monitoring purposes. They are designed to facilitate accurate gas analysis during anesthesia procedures.

  • How are these devices supplied?

    The device is supplied as a Class 2 medical device by Precision Thermoplastic Components, Inc., located at 1025 Findlay Rd., Lima, OH. It is intended for use in anesthesiology settings.

  • Is this device single-use or reusable?

    The available data does not specify whether this device is single-use or reusable. Users should consult the manufacturer's labeling or contact Precision Thermoplastic Components, Inc. for guidance on reuse and sterilization.

  • What regulatory status does this device have?

    This device has FDA 510(k) clearance under number K943874, granted on October 28, 1994. It is classified as a Class 2 medical device and was determined to be substantially equivalent to existing devices.

  • Are there any storage or MRI safety details provided?

    No information regarding storage conditions or MRI safety is provided in the available device data. For such details, refer to the product labeling or contact the manufacturer directly.