Cleared Traditional

K851235 - DEMAND OXYGEN SAUER DOS2 MODEL 10

K851235 is an FDA 510(k) clearance for DEMAND OXYGEN SAUER DOS2 MODEL 10, manufactured by Applied Membrane Technology, Inc.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K851235 · Applied Membrane Technology, Inc. · Anesthesiology device
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Apr 1985
Decision
35d
Days
Class 2
Risk

K851235 is an FDA 510(k) clearance for the DEMAND OXYGEN SAUER DOS2 MODEL 10. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Applied Membrane Technology, Inc. (Minnetonka, US). The FDA issued a Cleared decision on April 30, 1985 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 - K851235

510(k) Number K851235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1985
Decision Date April 30, 1985
Days to Decision 35 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 140d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFB Device Classification - Class 2, Special Controls

Product Code NFB Conserver, Oxygen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - NFB Conserver, Oxygen

All 64
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K851235.
MAXI-USE O2 DEVICE
K861325 · B & F Medical Products, Inc. · Sep 1986
BUNN MODEL 22 OXYGEN FLOW CONTROLLER
K861199 · The John Bunn Co. · Aug 1986
OXYMATICTM ELECTRONIC OXGYEN CONSERVER
K852650 · Chad Therapeutics, Inc. · Aug 1985
OXYMIZER-PENDANT
K834588 · Chad Therapeutics, Inc. · Mar 1984
OXYMIZER
K830009 · Chad Therapeutics, Inc. · Apr 1983
K851235 · DEMAND OXYGEN SAUER DOS2 MODEL 10
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