Cleared Special

K010389 - CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411

K010389 is an FDA 510(k) clearance for CHAD THERAPEUTICS OXYMATIC MODEL 401 AN..., manufactured by Chad Therapeutics, Inc.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Special 510(k) pathway after a 42-day FDA review.

K010389 · Chad Therapeutics, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
42d
Days
Class 2
Risk

K010389 is an FDA 510(k) clearance for the CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411. 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 March 23, 2001 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K010389

510(k) Number K010389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2001
Decision Date March 23, 2001
Days to Decision 42 days
Submission Type Special
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
98d faster than avg
Panel avg: 140d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

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 K010389.
CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
K020475 · Chad Therapeutics, Inc. · Jul 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
PM 1800 CONSERVING DEVICE
K001412 · Precision Medical, Inc. · Mar 2001
MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
K003455 · Chad Therapeutics, Inc. · Dec 2000
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
K002284 · Invacare Corp. · Oct 2000