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Criterion 40 OR PM 40

by Caradyne, Ltd.

510(k) K992101

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 NumberK992101 Date6 Jan 2000ClearedStatusActive

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  • Withdrawn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, 21 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 device is a Monitor, Airway Pressure (Includes Gauge And/Or Alarm) as defined in the nomenclature authority. It is substantially equivalent to a predicate device and classified as a Class II medical device under FDA regulation number 868.2600.

The device was cleared via the traditional 510(k) pathway (K992101) by Caradyne, Ltd. It is intended for use in anesthesiology settings and must be certified by an authorized technician prior to patient use.

Other devices from Caradyne, Ltd.

Questions

AI-generated answers, 21 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 CRITERION 40 OR PM 40 used for?

    The CRITERION 40 OR PM 40 is an airway pressure monitor that includes a gauge and/or alarm, intended for use in anesthesiology settings to monitor patient airway pressure during procedures.

  • How was the CRITERION 40 OR PM 40 cleared for market?

    The device was cleared through the traditional 510(k) pathway under submission K992101, demonstrating substantial equivalence to a predicate device and classified as a Class II medical device under FDA regulation 868.2600.

  • Who manufactures the CRITERION 40 OR PM 40 and where are they located?

    The CRITERION 40 OR PM 40 is manufactured by Caradyne, Ltd., located at 6329 W. Waterview Ct., Mccordsville, IN 46055, United States.