Skip to content

Sensormedics Oxyshuttle

by Sensor Medics Corp.

510(k) K862617

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 NumberK862617 Date26 Sep 1986ClearedStatusActive

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  • Withdrawn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)

Full name
Sensormedics Oxyshuttle(Tm)
510(k) Number
FDA Product Code
DQA
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Sensormedics Oxyshuttle is a Class 2 anesthesiology device designed for use in clinical settings to assist with patient monitoring during anesthesia. It functions as a pulse oximetry system, providing continuous measurement of oxygen saturation and related parameters.

The device was cleared by the FDA through a traditional 510(k) submission (K862617) on 26 September 1986, with product code DQA and advisory committee classification in cardiovascular. It is supplied by Sensor Medics Corp. and is identified as a single‑use, non‑reusable system; no specific sterility or MRI safety information is provided in the source data.

Other devices from Sensor Medics Corp.

See all devices from Sensor Medics Corp. →

Questions

AI-generated answers, 22 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 clinical purpose does the Sensormedics Oxyshuttle serve?

    The Oxyshuttle is a Class 2 anesthesiology device that provides continuous pulse oximetry, measuring a patient’s oxygen saturation and related parameters throughout the anesthesia period to help clinicians maintain adequate oxygenation.

  • Is the Oxyshuttle intended for single‑use or multiple uses?

    It is supplied as a single‑use, non‑reusable system. This design eliminates the need for reprocessing and helps ensure consistent performance for each patient.

  • How is the Oxyshuttle packaged and what storage considerations apply?

    The device is provided by Sensor Medics Corp. as a ready‑to‑use unit. While the source data does not specify sterility or MRI safety, standard practice is to store single‑use monitoring equipment in a clean, dry environment until needed.

  • Through which regulatory pathway was the Oxyshuttle cleared?

    The Oxyshuttle received FDA clearance via a traditional 510(k) submission (K862617) on 26 September 1986, demonstrating substantial equivalence to a predicate device and meeting the requirements for Class 2 cardiovascular monitoring devices.