Cleared Traditional

K020475 - CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511

K020475 is an FDA 510(k) clearance for CHAD THERAPEUTICS OXYPENUMATIC CYPRESS ..., manufactured by Chad Therapeutics, Inc.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K020475 · Chad Therapeutics, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
143d
Days
Class 2
Risk

K020475 is an FDA 510(k) clearance for the CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Chad Therapeutics, Inc. (Chatsworth, US). The FDA issued a Cleared decision on July 5, 2002 after a review of 143 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K020475

510(k) Number K020475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2002
Decision Date July 05, 2002
Days to Decision 143 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 140d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFB Device Classification - Class 2, Special Controls

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 62
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K020475.
AIRLIFE DEMAND NASAL CANNULA
K023673 · Allegiance Healthcare Corp. · May 2003
6203
K022865 · Contemporary Products, Inc. · Feb 2003
PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB
K023420 · Medical Electronic Devices, Inc. · Oct 2002
DEVILBISS PD1000
K020329 · Sunrise Medical Hhg, Inc. · Jun 2002
OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830
K010747 · Western Ent. · May 2001
CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411
K010389 · Chad Therapeutics, Inc. · Mar 2001