Cleared Traditional

K911740 - SALTER LABS NEONATAL NASAL OXYGEN CANNULA

K911740 is an FDA 510(k) clearance for SALTER LABS NEONATAL NASAL OXYGEN CANNULA, manufactured by Salter Labs. The device is a Class 1 Anesthesiology device with product code CAT cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K911740 · Salter Labs · Anesthesiology device
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Jul 1991
Decision
98d
Days
Class 1
Risk

K911740 is an FDA 510(k) clearance for the SALTER LABS NEONATAL NASAL OXYGEN CANNULA. Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on July 24, 1991 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5340 - 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

FDA 510(k) Submission Details - K911740

510(k) Number K911740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1991
Decision Date July 24, 1991
Days to Decision 98 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
42d faster than avg
Panel avg: 140d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

CAT Device Classification - Class 1, General Controls

Product Code CAT Cannula, Nasal, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5340
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CAT Cannula, Nasal, Oxygen

All 14
Devices cleared under the same product code (CAT) and FDA review panel - the closest regulatory comparables to K911740.
NASAL CANNULA
K935533 · Puritas Health Care, Inc. · Feb 1994
KENDALL CURITY OXYGEN NASAL CANNULA
K892435 · The Kendal Co. · Jun 1989
OXYGEN CANNULA EAR WRAP (STYLE A)
K863431 · Salter Labs · Sep 1986
OXYGEN CANNULA EAR WRAP (STYLE B)
K863432 · Salter Labs · Sep 1986
NASAL CANNULA W/2M & 5M TUBING
K860872 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
ARGYLE NASAL CANNULA
K833127 · Sherwood Medical Co. · Nov 1983