Cleared Traditional

K920622 - RASCAL II

K920622 is an FDA 510(k) clearance for RASCAL II, manufactured by Ohmeda Medical. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K920622 · Ohmeda Medical · Anesthesiology device
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Oct 1992
Decision
245d
Days
Class 2
Risk

K920622 is an FDA 510(k) clearance for the RASCAL II. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Ohmeda Medical (Salt Lake City, US). The FDA issued a Cleared decision on October 13, 1992 after a review of 245 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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 Ohmeda Medical devices

FDA 510(k) Submission Details - K920622

510(k) Number K920622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1992
Decision Date October 13, 1992
Days to Decision 245 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 140d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCK Device Classification - Class 2, Special Controls

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 231
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K920622.
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OHMEDA MODEL 5250 RGM MONITOR
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GAS SAMPLING INTERFACES
K914337 · Vital Signs, Inc. · Mar 1992
DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL
K915228 · Hospitak, Inc. · Feb 1992