Cleared Traditional

K090421 - MODEL 350G GAS CONSERVER

K090421 is an FDA 510(k) clearance for MODEL 350G GAS CONSERVER, manufactured by Inspired Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K090421 · Inspired Technologies, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
100d
Days
Class 2
Risk

K090421 is an FDA 510(k) clearance for the MODEL 350G GAS CONSERVER. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Inspired Technologies, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on May 29, 2009 after a review of 100 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 - K090421

510(k) Number K090421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2009
Decision Date May 29, 2009
Days to Decision 100 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
40d faster than avg
Panel avg: 140d · This submission: 100d
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
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