Cleared Traditional

K011125 - NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI

K011125 is an FDA 510(k) clearance for NASAL CANNULA, manufactured by Hudson Respiratory Care, Inc.. The device is a Class 1 Anesthesiology device with product code CAT cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K011125 · Hudson Respiratory Care, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
61d
Days
Class 1
Risk

K011125 is an FDA 510(k) clearance for the NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNUL.... Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by Hudson Respiratory Care, Inc. (Temecula, US). The FDA issued a Cleared decision on June 13, 2001 after a review of 61 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 - K011125

510(k) Number K011125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2001
Decision Date June 13, 2001
Days to Decision 61 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 140d · This submission: 61d
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 27
Devices cleared under the same product code (CAT) and FDA review panel - the closest regulatory comparables to K011125.
NASAL CANNULA
K935533 · Puritas Health Care, Inc. · Feb 1994
4 SURE TM NASAL OXYGEN CANNULA
K922397 · Boston Pacific Medical, Inc. · Mar 1993
SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED
K921496 · Alpine Specialties, Inc. · Aug 1992
CANNULA NASAL OXYGEN
K920573 · B & F Medical Products, Inc. · Aug 1992
NASAL OXYGEN CANNULA, 81585, 81587 & 81589
K913421 · Specialty Packaging Producs, Inc. · Oct 1991
SKIN SAVER(TM) TUBING HOLDER, MODEL 467
K912197 · Alpine Specialties, Inc. · Aug 1991
K011125 · NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI
Download PDF FDA Summary Hudson Respiratory Ca…