Cleared Traditional

K842978 - 540 CAPNOGRAPH

K842978 is an FDA 510(k) clearance for 540 CAPNOGRAPH, manufactured by Spacelabs, Inc.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K842978 · Spacelabs, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1984
Decision
25d
Days
Class 2
Risk

K842978 is an FDA 510(k) clearance for the 540 CAPNOGRAPH. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Spacelabs, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 24, 1984 after a review of 25 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 Spacelabs, Inc. devices

FDA 510(k) Submission Details - K842978

510(k) Number K842978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1984
Decision Date August 24, 1984
Days to Decision 25 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
115d faster than avg
Panel avg: 140d · This submission: 25d
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 152
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K842978.
MODEL IM1074 END-TIDAL CO2 MODULE
K843970 · Gould, Inc. · Oct 1984
CO2 TEST
K843844 · Erich Jaeger, Inc. · Oct 1984
OHMEDA MODEL 5200 CO2 MONITOR
K843599 · Ohmeda Medical · Oct 1984
ANESTHETIC GAS MONITOR SYS
K840966 · Marquest Medical Products, Inc. · May 1984
C02 MONITOR-OIR-7101
K841498 · Nihon Kohden America, Inc. · May 1984
TRI-MED 511 INFANT RESPIRATION MONITOR
K833397 · Tri-Med, Inc. · Nov 1983