Cleared Traditional

K992101 - CRITERION 40 OR PM 40

K992101 is an FDA 510(k) clearance for CRITERION 40 OR PM 40, manufactured by Caradyne, Ltd.. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K992101 · Caradyne, Ltd. · Anesthesiology device
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Jan 2000
Decision
198d
Days
Class 2
Risk

K992101 is an FDA 510(k) clearance for the CRITERION 40 OR PM 40. 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 January 6, 2000 after a review of 198 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2600 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Caradyne, Ltd. devices

FDA 510(k) Submission Details - K992101

510(k) Number K992101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1999
Decision Date January 06, 2000
Days to Decision 198 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 140d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K992101.
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