Cleared Traditional

Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula (K151506) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K151506 · Salter Labs · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
281d
Days
Class 2
Risk

K151506 is an FDA 510(k) clearance for the Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Salter Labs (Carlsbad, US). The FDA issued a Cleared decision on March 11, 2016 after a review of 281 days - an extended review 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: 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 Salter Labs devices

Submission Details

510(k) Number K151506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2015
Decision Date March 11, 2016
Days to Decision 281 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 140d · This submission: 281d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - NFB Conserver, Oxygen

Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K151506.
Proxima
K220591 · Dynasthetics, LLC · Dec 2022
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
EOCD
K041568 · Respironics, Inc. · Jul 2004
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
K002284 · Invacare Corp. · Oct 2000