Cleared Traditional

K020475 - CHAD THERAPEUTICS OXYPENUMATIC CYPRESS ...

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)
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.

View all Chad Therapeutics, Inc. devices

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
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 20
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K020475.
EOCD
K041568 · Respironics, Inc. · Jul 2004
EASY PULSE II OXYGEN CONSERVER
K032018 · Precision Medical, Inc. · Aug 2003
AIRLIFE DEMAND NASAL CANNULA
K023673 · Allegiance Healthcare Corp. · May 2003
PM 1800 CONSERVING DEVICE
K001412 · Precision Medical, Inc. · Mar 2001
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
K002284 · Invacare Corp. · Oct 2000
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
K990678 · Salter Labs · May 1999