Cleared Traditional

K883532 - ICOR AGENT MONITOR

K883532 is an FDA 510(k) clearance for ICOR AGENT MONITOR, manufactured by Icor AB. The device is a Class 2 Anesthesiology device with product code CBQ cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K883532 · Icor AB · Anesthesiology device
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Nov 1988
Decision
78d
Days
Class 2
Risk

K883532 is an FDA 510(k) clearance for the ICOR AGENT MONITOR. Classified as Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) (product code CBQ), Class II - Special Controls.

Submitted by Icor AB (Bromma, SE). The FDA issued a Cleared decision on November 4, 1988 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1500 - 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 Icor AB devices

FDA 510(k) Submission Details - K883532

510(k) Number K883532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1988
Decision Date November 04, 1988
Days to Decision 78 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 140d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBQ Device Classification - Class 2, Special Controls

Product Code CBQ Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1500
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 - CBQ Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)

All 17
Devices cleared under the same product code (CBQ) and FDA review panel - the closest regulatory comparables to K883532.
ANESTHETIC AGENT MONITOR
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OHMEDA 5330 AGENT MONITOR
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OHMEDA 5300 ANESTHETIC AGENT MONITOR
K861397 · Ohmeda Medical · May 1986
PB253 TO PB254 IR - SPECTROMETER UPGRADE KIT
K861474 · Datex Division Instrumentarium Corp. · May 1986