Cleared Traditional

K853378 - AUTO PRO

K853378 is an FDA 510(k) clearance for AUTO PRO, manufactured by Respiration Technology, Inc.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K853378 · Respiration Technology, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1985
Decision
38d
Days
Class 2
Risk

K853378 is an FDA 510(k) clearance for the AUTO PRO. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Respiration Technology, Inc. (Denver, US). The FDA issued a Cleared decision on September 19, 1985 after a review of 38 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 - K853378

510(k) Number K853378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date September 19, 1985
Days to Decision 38 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 140d · This submission: 38d
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 K853378.
COMPANION OXYGEN SAVER
K863695 · Puritan Bennett Corp. · Oct 1986
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
K853378 · AUTO PRO
Download PDF Respiration Technolog…