Cleared Traditional

K001579 - IMPULSE SELECT

K001579 is an FDA 510(k) clearance for IMPULSE SELECT, manufactured by Airsep Corp.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K001579 · Airsep Corp. · Anesthesiology device
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Aug 2000
Decision
101d
Days
Class 2
Risk

K001579 is an FDA 510(k) clearance for the IMPULSE SELECT. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Airsep Corp. (Buffalo, US). The FDA issued a Cleared decision on August 31, 2000 after a review of 101 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 Airsep Corp. devices

FDA 510(k) Submission Details - K001579

510(k) Number K001579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2000
Decision Date August 31, 2000
Days to Decision 101 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 140d · This submission: 101d
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 18
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K001579.
AIRLIFE DEMAND NASAL CANNULA
K023673 · Allegiance Healthcare Corp. · May 2003
PM 1800 CONSERVING DEVICE
K001412 · Precision Medical, Inc. · Mar 2001
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
MODEL IPD OXYGEN CONSERVING DEVICE
K953852 · Invacare Corp. · Nov 1995