Cleared Traditional

K890141 - DEVILBISS MODEL 1400D (OXYGEN CONSERVIN...

K890141 is the FDA 510(k) clearance for DEVILBISS MODEL 1400D (OXYGEN CONSERVIN... by Devilbiss Health Care, Inc.. It is a Class 2 Anesthesiology device (product code NFB) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K890141 · Devilbiss Health Care, Inc. · Anesthesiology device
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Apr 1989
Decision
83d
Days
Class 2
Risk

K890141 is an FDA 510(k) clearance for the DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE). Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Devilbiss Health Care, Inc. (Somerset, US). The FDA issued a Cleared decision on April 6, 1989 after a review of 83 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.

View all Devilbiss Health Care, Inc. devices

Submission Details

510(k) Number K890141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1989
Decision Date April 06, 1989
Days to Decision 83 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 140d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 9
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K890141.
EOCD
K041568 · Respironics, Inc. · Jul 2004
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
K002284 · Invacare Corp. · Oct 2000
MODEL IPD OXYGEN CONSERVING DEVICE
K953852 · Invacare Corp. · Nov 1995
COMPANION MINI OXYGEN SAVER
K873901 · Puritan Bennett Corp. · Dec 1987
COMPANION OXYGEN SAVER
K863695 · Puritan Bennett Corp. · Oct 1986