Cleared Traditional

K023120 - OXYCON MOBILE

K023120 is an FDA 510(k) clearance for OXYCON MOBILE, manufactured by Erich Jaeger GmbH. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 419-day FDA review.

K023120 · Erich Jaeger GmbH · Anesthesiology device
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Nov 2003
Decision
419d
Days
Class 2
Risk

K023120 is an FDA 510(k) clearance for the OXYCON MOBILE. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Erich Jaeger GmbH (Yorba Linda, US). The FDA issued a Cleared decision on November 12, 2003 after a review of 419 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Erich Jaeger GmbH devices

FDA 510(k) Submission Details - K023120

510(k) Number K023120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2002
Decision Date November 12, 2003
Days to Decision 419 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
279d slower than avg
Panel avg: 140d · This submission: 419d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZC Device Classification - Class 2, Special Controls

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 - BZC Calculator, Pulmonary Function Data

All 39
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