Cleared Traditional

K870911 - INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY

K870911 is an FDA 510(k) clearance for INDWELLING BLOOD CARBONDIOXIDE PARTIAL ..., manufactured by American Bentley. The device is a Class 2 Anesthesiology device with product code CCC cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K870911 · American Bentley · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1987
Decision
84d
Days
Class 2
Risk

K870911 is an FDA 510(k) clearance for the INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY. Classified as Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling (product code CCC), Class II - Special Controls.

Submitted by American Bentley (Irvine, US). The FDA issued a Cleared decision on May 29, 1987 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1150 - 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 American Bentley devices

FDA 510(k) Submission Details - K870911

510(k) Number K870911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1987
Decision Date May 29, 1987
Days to Decision 84 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
56d faster than avg
Panel avg: 140d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCC Device Classification - Class 2, Special Controls

Product Code CCC Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1150
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 - CCC Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling

Devices cleared under the same product code (CCC) and FDA review panel - the closest regulatory comparables to K870911.
PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM
K972314 · Diametrics Medical, Ltd. · Dec 1997
BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS
K901548 · Shiley, Inc. · Jan 1991
MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING
K891013 · Medtronic Vascular · Aug 1989
OXYGEN ANALYZER 110
K780185 · Siemens Corp. · Mar 1978
SENSOMAT
K771722 · Biochem International, Inc. · Sep 1977
ANALYZER, SENTORR BLOOD GAS
K760088 · Ohio Medical Products · Aug 1976