Cleared Traditional

K011134 - OXYGEN SUPPLY TUBING, MODEL 1115

K011134 is an FDA 510(k) clearance for OXYGEN SUPPLY TUBING, manufactured by Hudson Respiratory Care, Inc.. The device is a Class 1 Anesthesiology device with product code BYX cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K011134 · 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

K011134 is an FDA 510(k) clearance for the OXYGEN SUPPLY TUBING, MODEL 1115. Classified as Tubing, Pressure And Accessories (product code BYX), 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 868.5860 - 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 - K011134

510(k) Number K011134 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.

BYX Device Classification - Class 1, General Controls

Product Code BYX Tubing, Pressure And Accessories
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5860
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 - BYX Tubing, Pressure And Accessories

All 41
Devices cleared under the same product code (BYX) and FDA review panel - the closest regulatory comparables to K011134.
NORTH STATE PLASTICS AEROSOL TEE
K955656 · North State Plastics, Inc. · Mar 1996
GAS SAMPLING INTERFACES
K943110 · Coast Medical, Inc. · Aug 1994
BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES
K935835 · Busse Hospital Disposables, Inc. · Jan 1994
MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS
K931033 · Medical Fittings, Inc. · Jun 1993
MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS
K931043 · Medical Fittings, Inc. · Jun 1993
OXYGEN TUBING, 81503
K913422 · Specialty Packaging Producs, Inc. · Jan 1992
K011134 · OXYGEN SUPPLY TUBING, MODEL 1115
Download PDF FDA Summary Hudson Respiratory Ca…