Cleared Traditional

K892435 - KENDALL CURITY OXYGEN NASAL CANNULA

K892435 is an FDA 510(k) clearance for KENDALL CURITY OXYGEN NASAL CANNULA, manufactured by The Kendal Co.. The device is a Class 1 Anesthesiology device with product code CAT cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K892435 · The Kendal Co. · Anesthesiology device
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Jun 1989
Decision
63d
Days
Class 1
Risk

K892435 is an FDA 510(k) clearance for the KENDALL CURITY OXYGEN NASAL CANNULA. Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by The Kendal Co. (Boston, US). The FDA issued a Cleared decision on June 12, 1989 after a review of 63 days - a notably fast clearance cycle.

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: 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 The Kendal Co. devices

FDA 510(k) Submission Details - K892435

510(k) Number K892435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1989
Decision Date June 12, 1989
Days to Decision 63 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
77d faster than avg
Panel avg: 140d · This submission: 63d
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 K892435.
NASAL CANNULA
K935533 · Puritas Health Care, Inc. · Feb 1994
SALTER LABS NEONATAL NASAL OXYGEN CANNULA
K911740 · Salter Labs · Jul 1991
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