Cleared Traditional

K770721 - MONITORS

K770721 is an FDA 510(k) clearance for MONITORS, manufactured by The Perkin-Elmer Corp.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K770721 · The Perkin-Elmer Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1977
Decision
10d
Days
Class 2
Risk

K770721 is an FDA 510(k) clearance for the MONITORS, REMOTE, RMS III. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by The Perkin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on April 28, 1977 after a review of 10 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 The Perkin-Elmer Corp. devices

FDA 510(k) Submission Details - K770721

510(k) Number K770721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1977
Decision Date April 28, 1977
Days to Decision 10 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
130d faster than avg
Panel avg: 140d · This submission: 10d
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 151
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K770721.
MONITOR, BECKMAN LB-3CO2
K782138 · Beckman Instruments, Inc. · Jan 1979
CAPNOMETER MODEL 47210A
K780324 · Hewlett-Packard Co. · Mar 1978
MONITOR, PATIENT, MODEL PM-I0N
K770968 · Cavitron Corp. · Jun 1977
MONITOR, PATIENT, RESP. CARBON DIOXIDE
K770713 · Cavitron Corp. · Apr 1977
EXERCISE RESPIRATORY GAS ANALYZER
K770123 · Respironics, Inc. · Feb 1977