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Anesthesia Extension Tubes

by David Simmonds Co., Inc. 510(k)

Active United States

510(k) K820527

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK820527 Date18 Mar 1982ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

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, 24 Sep 2026

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

Anesthesia extension tubes are tubing devices used for fluid delivery in anesthesia applications. They are classified as Tubing, Fluid Delivery under regulation number 880.5440 and are intended for use in general hospital settings.

The device received FDA 510(k) clearance (K820527) on March 18, 1982, and is classified as a Class II medical device. It is manufactured by David Simmonds Co., Inc. and is supplied as a non-sterile, reusable device unless otherwise specified in labeling.

Other devices from David Simmonds Co., Inc.

Questions

AI-generated answers, 24 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 are anesthesia extension tubes used for?

    Anesthesia extension tubes are tubing devices used for fluid delivery in anesthesia applications, intended for use in general hospital settings as specified in the device description and regulation number 880.5440.

  • Are anesthesia extension tubes sterile or non-sterile, and are they single-use or reusable?

    The device is supplied as a non-sterile, reusable device unless otherwise specified in labeling, meaning it is designed for multiple uses after appropriate cleaning and reprocessing by the healthcare facility.

  • What regulatory pathway was used for anesthesia extension tubes, and what is the clearance number?

    The device received FDA 510(k) clearance under the traditional pathway, with clearance number K820527, granted on March 18, 1982, and is classified as a Class II medical device under regulation 880.5440.