Cleared Traditional

K000890 - CHAD THERAPEUTICS OXYMATIC MODEL 401

K000890 is an FDA 510(k) clearance for CHAD THERAPEUTICS OXYMATIC MODEL 401, 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 88-day FDA review.

K000890 · Chad Therapeutics, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
88d
Days
Class 2
Risk

K000890 is an FDA 510(k) clearance for the CHAD THERAPEUTICS OXYMATIC MODEL 401. 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 June 16, 2000 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K000890

510(k) Number K000890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2000
Decision Date June 16, 2000
Days to Decision 88 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
52d faster than avg
Panel avg: 140d · This submission: 88d
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 K000890.
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
K002284 · Invacare Corp. · Oct 2000
IMPULSE SELECT
K001579 · Airsep Corp. · Aug 2000
OCD2001
K992935 · Contemporary Products, Inc. · Jun 2000
O2N DEMAND-II, VICTOR MODEL OCPR-II
K992659 · Thermadyne Holings Corp. · Sep 1999
TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000
K982943 · Transtracheal Systems · Jul 1999
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
K990678 · Salter Labs · May 1999