Cleared Traditional

K861213 - PB 254 IR - SPECTROMETER

K861213 is the FDA 510(k) clearance for PB 254 IR - SPECTROMETER by Datex Division Instrumentarium Corp.. It is a Class 2 Anesthesiology device (product code CCK) cleared through the Traditional 510(k) pathway after a 4-day FDA review.

K861213 · Datex Division Instrumentarium Corp. · Anesthesiology device
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Apr 1986
Decision
4d
Days
Class 2
Risk

K861213 is an FDA 510(k) clearance for the PB 254 IR - SPECTROMETER. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on April 4, 1986 after a review of 4 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 Datex Division Instrumentarium Corp. devices

Submission Details

510(k) Number K861213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1986
Decision Date April 04, 1986
Days to Decision 4 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d faster than avg
Panel avg: 140d · This submission: 4d
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
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CAPNOMED
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