Cleared Abbreviated

K000959 - CRITERION 60 OR PM 60

K000959 is an FDA 510(k) clearance for CRITERION 60 OR PM 60, manufactured by Caradyne, Ltd.. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K000959 · Caradyne, Ltd. · Anesthesiology device
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Jun 2000
Decision
90d
Days
Class 2
Risk

K000959 is an FDA 510(k) clearance for the CRITERION 60 OR PM 60. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Caradyne, Ltd. (Mccordsville, US). The FDA issued a Cleared decision on June 22, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2600 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Caradyne, Ltd. devices

FDA 510(k) Submission Details - K000959

510(k) Number K000959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2000
Decision Date June 22, 2000
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

CAP Device Classification - Class 2, Special Controls

Product Code CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)

All 41
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K000959.
AMBU DISPOSABLE PRESSURE MANOMETER
K040991 · Ambu, Inc. · Jul 2004
DISPOSABLE PRESSURE MANOMETER
K022402 · Vital Signs, Inc. · Aug 2002
DISPOSABLE PRESSURE MONITOR
K003497 · Engineered Medical Systems · Nov 2000
1ST RESPONSE DISPOSABLE MANOMETER
K961318 · Intertech Resources, Inc. · Dec 1996
RESPIRONICS' DIGITAL MANOMETER
K904935 · Respironics, Inc. · Apr 1991
RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)
K902276 · Respironics, Inc. · Aug 1990