Cleared Traditional

K992214 - OXYCON PRO

K992214 is an FDA 510(k) clearance for OXYCON PRO, manufactured by Erich Jaeger B.V.. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K992214 · Erich Jaeger B.V. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
236d
Days
Class 2
Risk

K992214 is an FDA 510(k) clearance for the OXYCON PRO. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Erich Jaeger B.V. (Nl-3981 La Bunnik, NL). The FDA issued a Cleared decision on February 22, 2000 after a review of 236 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. 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 Erich Jaeger B.V. devices

FDA 510(k) Submission Details - K992214

510(k) Number K992214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1999
Decision Date February 22, 2000
Days to Decision 236 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 140d · This submission: 236d
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 34
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K992214.
Vyntus/SentrySuite Product Line
K183567 · Vyaire Medical · Aug 2019
Vyntus BODY
K190853 · Vyaire Medical, Inc. · Aug 2019
Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
K181524 · Vyaire Medical, Inc. · Nov 2018
COSMO PLUS WITH NICO, MODEL 8200
K982499 · Novametrix Medical Systems, Inc. · Oct 1998
CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO
K982487 · Cardiopulmonary Technologies, Inc. · Oct 1998
INTELLIFLOW RESPIRATORY ANALYZER
K970840 · Simtec, Inc. · Nov 1997