Cleared Traditional

K896036 - THE COMFORTABLE CANNULA

K896036 is an FDA 510(k) clearance for THE COMFORTABLE CANNULA, manufactured by Comfortable Concepts Corp.. The device is a Class 1 Anesthesiology device with product code CAT cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K896036 · Comfortable Concepts Corp. · Anesthesiology device
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Nov 1989
Decision
31d
Days
Class 1
Risk

K896036 is an FDA 510(k) clearance for the THE COMFORTABLE CANNULA. Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by Comfortable Concepts Corp. (Copiague, US). The FDA issued a Cleared decision on November 17, 1989 after a review of 31 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.

FDA 510(k) Submission Details - K896036

510(k) Number K896036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1989
Decision Date November 17, 1989
Days to Decision 31 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
109d faster than avg
Panel avg: 140d · This submission: 31d
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 22
Devices cleared under the same product code (CAT) and FDA review panel - the closest regulatory comparables to K896036.
4 SURE TM NASAL OXYGEN CANNULA
K922397 · Boston Pacific Medical, Inc. · Mar 1993
CANNULA NASAL OXYGEN
K920573 · B & F Medical Products, Inc. · Aug 1992
SALTER LABS NEONATAL NASAL OXYGEN CANNULA
K911740 · Salter Labs · Jul 1991
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
K896036 · THE COMFORTABLE CANNULA
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