Cleared Traditional

K770968 - MONITOR, PATIENT, MODEL PM-I0N

K770968 is an FDA 510(k) clearance for MONITOR, manufactured by Cavitron Corp.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K770968 · Cavitron Corp. · Anesthesiology device
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Jun 1977
Decision
8d
Days
Class 2
Risk

K770968 is an FDA 510(k) clearance for the MONITOR, PATIENT, MODEL PM-I0N. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Cavitron Corp. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1977 after a review of 8 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cavitron Corp. devices

FDA 510(k) Submission Details - K770968

510(k) Number K770968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1977
Decision Date June 08, 1977
Days to Decision 8 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
132d faster than avg
Panel avg: 140d · This submission: 8d
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 204
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K770968.
IL MODEL END TIDAL CO2 ANALYZER
K791570 · Instrumentation Laboratory CO · Sep 1979
MONITOR, BECKMAN LB-3CO2
K782138 · Beckman Instruments, Inc. · Jan 1979
CAPNOMETER MODEL 47210A
K780324 · Hewlett-Packard Co. · Mar 1978
MONITORS, REMOTE, RMS III
K770721 · The Perkin-Elmer Corp. · Apr 1977
MONITOR, PATIENT, RESP. CARBON DIOXIDE
K770713 · Cavitron Corp. · Apr 1977
EXERCISE RESPIRATORY GAS ANALYZER
K770123 · Respironics, Inc. · Feb 1977