Cleared Traditional

K843811 - BUNN 3001 OXYGEN CONCENTRATOR

K843811 is the FDA 510(k) clearance for BUNN 3001 OXYGEN CONCENTRATOR by The John Bunn Co.. It is a Class 2 Anesthesiology device (product code CAW) cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K843811 · The John Bunn Co. · Anesthesiology device
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Oct 1984
Decision
6d
Days
Class 2
Risk

K843811 is an FDA 510(k) clearance for the BUNN 3001 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. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1984 after a review of 6 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

Submission Details

510(k) Number K843811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1984
Decision Date October 04, 1984
Days to Decision 6 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d faster than avg
Panel avg: 140d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 70
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K843811.
PRIME AIRE O2 PLUS 2
K851437 · Invacare Corp. · Jul 1985
MOBILAIRE II(P2A) OXYGEN CONCENTRATOR
K851438 · Invacare Corp. · Jul 1985
MOBILAIRE, PLA-01 OXYGEN CONCENTRATOR
K851439 · Invacare Corp. · Jul 1985
COMPANION 492 OXYGEN CONCENTRATOR
K843243 · Puritan Bennett Corp. · Aug 1984
OXYGEN CONCENTRATOR
K823524 · C.R. Bard, Inc. · Dec 1982
LINDE OXYGEN CONCENTRATOR LOC-II
K791437 · Union Carbide Corp. · Sep 1979