Cleared Traditional

6203 (K022865) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K022865 · Contemporary Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
169d
Days
Class 2
Risk

K022865 is an FDA 510(k) clearance for the 6203. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Contemporary Products, Inc. (Portland, US). The FDA issued a Cleared decision on February 13, 2003 after a review of 169 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 Contemporary Products, Inc. devices

Submission Details

510(k) Number K022865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2002
Decision Date February 13, 2003
Days to Decision 169 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 140d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NFB Conserver, Oxygen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - NFB Conserver, Oxygen

All 9
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K022865.
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
K221014 · Effortless Oxygen, LLC · Oct 2022
Apogee
K200401 · Incoba Ltd D/B/A Dynaris · Nov 2020
EOCD
K041568 · Respironics, Inc. · Jul 2004
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
K002284 · Invacare Corp. · Oct 2000
MODEL IPD OXYGEN CONSERVING DEVICE
K953852 · Invacare Corp. · Nov 1995
COMPANION MINI OXYGEN SAVER
K873901 · Puritan Bennett Corp. · Dec 1987