Cleared Traditional

K862069 - CARDIOMET 4000 GAS MONITORING SYSTEMS

K862069 is an FDA 510(k) clearance for CARDIOMET 4000 GAS MONITORING SYSTEMS, manufactured by Biomedical Sensors, Inc.. The device is a Class 2 Cardiovascular device with product code DRY cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K862069 · Biomedical Sensors, Inc. · Cardiovascular device
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Jul 1986
Decision
49d
Days
Class 2
Risk

K862069 is an FDA 510(k) clearance for the CARDIOMET 4000 GAS MONITORING SYSTEMS. Classified as Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (product code DRY), Class II - Special Controls.

Submitted by Biomedical Sensors, Inc. (Buckinghamshire, England, GB). The FDA issued a Cleared decision on July 18, 1986 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4330 - the FDA cardiovascular device oversight 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.

FDA 510(k) Submission Details - K862069

510(k) Number K862069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1986
Decision Date July 18, 1986
Days to Decision 49 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRY Device Classification - Class 2, Special Controls

Product Code DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4330
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass

All 46
Devices cleared under the same product code (DRY) and FDA review panel - the closest regulatory comparables to K862069.
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K862953 · Classic Medical Products, Inc. · Aug 1986
CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000
K861277 · Critichem, Inc. · Jun 1986
GEM-6, WITH COMPONENTS
K854357 · Diamond Electro-Tech, Inc. · Jan 1986
HEMATOCRIT-SATURATION MONITOR HSM-100
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K862069 · CARDIOMET 4000 GAS MONITORING SYSTEMS
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