Cleared Traditional

K861435 - BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE

K861435 is an FDA 510(k) clearance for BUNN CONCENTRATOR MODEL 2011 WITH DEMAN..., 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 204-day FDA review.

K861435 · The John Bunn Co. · Anesthesiology device
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Nov 1986
Decision
204d
Days
Class 2
Risk

K861435 is an FDA 510(k) clearance for the BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE. 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 November 7, 1986 after a review of 204 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all The John Bunn Co. devices

FDA 510(k) Submission Details - K861435

510(k) Number K861435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1986
Decision Date November 07, 1986
Days to Decision 204 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
64d slower than avg
Panel avg: 140d · This submission: 204d
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 K861435.
BUNN CONCENTRATOR MODEL 2100 SERIES
K873071 · The John Bunn Co. · Sep 1987
CRITERION II & IIA OXYGEN CONCENTRATORS
K871603 · Timeter Instrument Corp. · Aug 1987
ALPINE
K864005 · Mountain Medical Equipment, Inc. · Jan 1987
PORTABLE OXYGEN GENERATOR
K864045 · Mountain Medical Equipment, Inc. · Nov 1986
SILENT PARTNER MODEL 10-2001
K861011 · Medical Devices, Inc. · Apr 1986
SILENT PARTNER MODEL 10-1001
K861012 · Medical Devices, Inc. · Apr 1986