Cleared Abbreviated

CRITERION 60 OR PM 60 (K000959) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K000959 · Caradyne, Ltd. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 9
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K000959.
VORTRAN APM-Plus
K182292 · Vortran Medical Technology 1, Inc. · Sep 2019
NS 120P-TRS Airway Pressure Gauge
K180510 · Instrumentation Industries, Inc. · May 2019
NAPA LP-15 Airway Pressure Monitor
K172284 · Drw Medical, LLC · Feb 2018
RESPIRONICS' DIGITAL MANOMETER
K904935 · Respironics, Inc. · Apr 1991
RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)
K902276 · Respironics, Inc. · Aug 1990
OHMEDA 5500 AIRWAY PRESSURE MONITOR
K864536 · Ohmeda Medical · Jan 1987