Cleared Traditional

K812643 - LIFESPAN CO2

K812643 is the FDA 510(k) clearance for LIFESPAN CO2 by Biochem International, Inc.. It is a Class 2 Anesthesiology device (product code CCK) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K812643 · Biochem International, Inc. · Anesthesiology device
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Nov 1981
Decision
61d
Days
Class 2
Risk

K812643 is an FDA 510(k) clearance for the LIFESPAN CO2. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Biochem International, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1981 after a review of 61 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 Biochem International, Inc. devices

Submission Details

510(k) Number K812643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1981
Decision Date November 16, 1981
Days to Decision 61 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 140d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 80
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K812643.
C02 MONITOR-OIR-7101
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CAPNOMETER W/NEW AIRWAY ADAPTER 47210A
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CAPNOGRAPH
K831776 · Datascope Corp. · Oct 1983
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