Cleared Special

K070740 - CHAD THERAPEUTICS BONSAI MODEL 800

K070740 is an FDA 510(k) clearance for CHAD THERAPEUTICS BONSAI MODEL 800, 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 52-day FDA review.

K070740 · Chad Therapeutics, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
52d
Days
Class 2
Risk

K070740 is an FDA 510(k) clearance for the CHAD THERAPEUTICS BONSAI MODEL 800. 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 May 7, 2007 after a review of 52 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 - K070740

510(k) Number K070740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2007
Decision Date May 07, 2007
Days to Decision 52 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
88d faster than avg
Panel avg: 140d · This submission: 52d
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 K070740.
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION
K113111 · Inovo, Inc. · Dec 2011
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER
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MODEL 350G GAS CONSERVER
K090421 · Inspired Technologies, Inc. · May 2009
INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR
K060751 · Inovo, Inc. · Jul 2006
FLO-RITE, MODEL 478-1
K060382 · Ameriflo Corp. · Apr 2006
INOGEN SATELLITE CONSERVER, MODEL SC-100
K052563 · Medical Electronic Devices, Inc. · Oct 2005