Cleared Traditional

K860060 - RX02 PLUS OXYGEN CONCENTRATOR

K860060 is an FDA 510(k) clearance for RX02 PLUS OXYGEN CONCENTRATOR, manufactured by The John Bunn Co.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K860060 · The John Bunn Co. · Anesthesiology device
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Feb 1986
Decision
30d
Days
Class 2
Risk

K860060 is an FDA 510(k) clearance for the RX02 PLUS OXYGEN CONCENTRATOR. Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by The John Bunn Co. (Tonawanda, US). The FDA issued a Cleared decision on February 5, 1986 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - 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 John Bunn Co. devices

FDA 510(k) Submission Details - K860060

510(k) Number K860060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1986
Decision Date February 05, 1986
Days to Decision 30 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
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAW Device Classification - Class 2, Special Controls

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAW Generator, Oxygen, Portable

All 138
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K860060.
SILENT PARTNER MODEL 10-2001
K861011 · Medical Devices, Inc. · Apr 1986
SILENT PARTNER MODEL 10-1001
K861012 · Medical Devices, Inc. · Apr 1986
BUNN LITE OXYGEN CONCENTRATOR
K855208 · The John Bunn Co. · Feb 1986
OXYGEN CONCENTRATOR, MODEL BX-5000
K854374 · Healthdyne, Inc. · Jan 1986
PORTABLE OXYGEN UNIT
K853004 · B & F Medical Products, Inc. · Aug 1985
SIERRA -OXYGEN CONCENTRATE
K852144 · Mountain Medical Equipment, Inc. · Aug 1985