Cleared Traditional

K890298 - DEMAND NASAL OXYGEN CANNULA MODELS 4008...

K890298 is an FDA 510(k) clearance for DEMAND NASAL OXYGEN CANNULA MODELS 4008..., manufactured by Salter Labs. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K890298 · Salter Labs · Anesthesiology device
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Feb 1989
Decision
35d
Days
Class 2
Risk

K890298 is an FDA 510(k) clearance for the DEMAND NASAL OXYGEN CANNULA MODELS 4008/4108/4208. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on February 23, 1989 after a review of 35 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Salter Labs devices

FDA 510(k) Submission Details - K890298

510(k) Number K890298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1989
Decision Date February 23, 1989
Days to Decision 35 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 140d · This submission: 35d
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 17
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K890298.
MODEL IPD OXYGEN CONSERVING DEVICE
K953852 · Invacare Corp. · Nov 1995
MODIFIED DEMAND NASAL OXYGEN CANNULA
K892407 · Salter Labs · Jul 1989
DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE)
K890141 · Devilbiss Health Care, Inc. · Apr 1989
COMPANION MINI OXYGEN SAVER
K873901 · Puritan Bennett Corp. · Dec 1987
COMPANION OXYGEN SAVER
K863695 · Puritan Bennett Corp. · Oct 1986