Cleared Traditional

K953852 - MODEL IPD OXYGEN CONSERVING DEVICE

K953852 is an FDA 510(k) clearance for MODEL IPD OXYGEN CONSERVING DEVICE, manufactured by Invacare Corp.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K953852 · Invacare Corp. · Anesthesiology device
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Nov 1995
Decision
98d
Days
Class 2
Risk

K953852 is an FDA 510(k) clearance for the MODEL IPD OXYGEN CONSERVING DEVICE. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on November 22, 1995 after a review of 98 days - within the typical 510(k) review window.

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: 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 Invacare Corp. devices

FDA 510(k) Submission Details - K953852

510(k) Number K953852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1995
Decision Date November 22, 1995
Days to Decision 98 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 140d · This submission: 98d
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 17
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K953852.
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
K002284 · Invacare Corp. · Oct 2000
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
K990678 · Salter Labs · May 1999
PULSE DOSE SERIES
K961126 · Devilbiss Health Care, Inc. · Oct 1996
MODIFIED DEMAND NASAL OXYGEN CANNULA
K892407 · Salter Labs · Jul 1989
DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE)
K890141 · Devilbiss Health Care, Inc. · Apr 1989
DEMAND NASAL OXYGEN CANNULA MODELS 4008/4108/4208
K890298 · Salter Labs · Feb 1989