Cleared Traditional

K041057 - FLO-RITE

K041057 is an FDA 510(k) clearance for FLO-RITE, manufactured by Ameriflo Corp.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K041057 · Ameriflo Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
111d
Days
Class 2
Risk

K041057 is an FDA 510(k) clearance for the FLO-RITE. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Ameriflo Corp. (Carmel, US). The FDA issued a Cleared decision on August 12, 2004 after a review of 111 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.

View all Ameriflo Corp. devices

FDA 510(k) Submission Details - K041057

510(k) Number K041057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2004
Decision Date August 12, 2004
Days to Decision 111 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 140d · This submission: 111d
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 20
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K041057.
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
K221014 · Effortless Oxygen, LLC · Oct 2022
Apogee
K200401 · Incoba Ltd D/B/A Dynaris · Nov 2020
Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
K151506 · Salter Labs · Mar 2016
EOCD
K041568 · Respironics, Inc. · Jul 2004
EASY PULSE II OXYGEN CONSERVER
K032018 · Precision Medical, Inc. · Aug 2003
AIRLIFE DEMAND NASAL CANNULA
K023673 · Allegiance Healthcare Corp. · May 2003