Cleared Traditional

K812643 - LIFESPAN CO2

K812643 is an FDA 510(k) clearance for LIFESPAN CO2, manufactured by Biochem International, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K812643

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
Combination Product No
PCCP Authorized No
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.

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 192
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K812643.
ADVANTAGE #1700
K832767 · The Perkin-Elmer Corp. · Nov 1983
CAPNOGRAPH
K831776 · Datascope Corp. · Oct 1983
ENGSTROM ELIZA CO2 ANALYZER
K823049 · Lkb Instruments, Inc. · Jan 1983
RESPIRATORY INTENSIVE CARE SYSTEM (RICS)
K810927 · Allied Healthcare Products, Inc. · Apr 1981
SIEMENS-ELEMA AB CO2 MONITOR 130
K802459 · Siemens Elema AB · Oct 1980
MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA
K800869 · Cavitron Corp. · May 1980