Cleared Special

K060382 - FLO-RITE, MODEL 478-1 (FDA 510(k) Clearance)

Also includes:
FLO-RITE II, MODEL 478-1 SIMPULSE II, MODEL 478-2S NUMATIX, MODEL NCD401 SIMPULSE, MODEL 478-1

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K060382 · Ameriflo Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
64d
Days
Class 2
Risk

K060382 is an FDA 510(k) clearance for the FLO-RITE, MODEL 478-1. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Ameriflo Corp. (Carmel, US). The FDA issued a Cleared decision on April 19, 2006 after a review of 64 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.

View all Ameriflo Corp. devices

Submission Details

510(k) Number K060382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2006
Decision Date April 19, 2006
Days to Decision 64 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 139d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.