Cleared Traditional

K942230 - OXYCON-ALPHA

K942230 is an FDA 510(k) clearance for OXYCON-ALPHA, manufactured by Mijnhardt B.V.. The device is a Class 2 Anesthesiology device with product code BTY cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K942230 · Mijnhardt B.V. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
318d
Days
Class 2
Risk

K942230 is an FDA 510(k) clearance for the OXYCON-ALPHA. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Mijnhardt B.V. (3981 Ae Bunnik, NL). The FDA issued a Cleared decision on March 20, 1995 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1890 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mijnhardt B.V. devices

FDA 510(k) Submission Details - K942230

510(k) Number K942230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1994
Decision Date March 20, 1995
Days to Decision 318 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
178d slower than avg
Panel avg: 140d · This submission: 318d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTY Device Classification - Class 2, Special Controls

Product Code BTY Calculator, Predicted Values, Pulmonary Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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 - BTY Calculator, Predicted Values, Pulmonary Function

All 40
Devices cleared under the same product code (BTY) and FDA review panel - the closest regulatory comparables to K942230.
STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES
K981366 · Sensor Medics Corp. · Oct 1998
MODIFICATION TO THE OXYCONALPHA
K980094 · Erich Jaeger B.V. · Jul 1998
DSXL DIFFUSION SPIROMETER
K961252 · Inair , Ltd. · Feb 1997
VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
K942211 · Sensor Medics Corp. · Nov 1994
FLOWSCREEN
K932744 · Erich Jaeger, Inc. · Mar 1994
MASTER SCREEN PNUEMO
K933839 · Erich Jaeger, Inc. · Mar 1994