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Manometer

by Intersurgical, Inc.

510(k) K122077

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 NumberK122077 Date10 Jan 2013ClearedStatusActive

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  • Withdrawn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
CAP
Device Class
Class II
Regulation
21 CFR Part 868.2600
Advisory Committee
Anesthesiology
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 Manometer is a device used for monitoring airway pressure during ventilation. It is classified as a Monitor, Airway Pressure, which includes a gauge and/or alarm.

The Manometer is supplied as a single patient use device. It has been cleared under FDA 510K with the regulation number 868.2600 and is classified under the product code CAP. The device is manufactured by Intersurgical, Inc. and has the registration number 3013557562, among others.

Other devices from Intersurgical, Inc.

See all devices from Intersurgical, Inc. →

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 is the Manometer used for?

    The Manometer is used for monitoring airway pressure during ventilation, providing a gauge and/or alarm to ensure patient safety.

  • Is the Manometer a single-use device?

    Yes, the Manometer is supplied as a single patient use device, reducing the risk of cross-contamination and ensuring patient safety.

  • What is the regulatory status of the Manometer?

    The Manometer has been cleared under FDA 510K with the regulation number 868.2600, classified under the product code CAP.