Cleared Abbreviated

K021981 - IVENT 201 PORTABLE VENTILATOR (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K021981 · Versamed , Ltd. · Anesthesiology device
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Aug 2003
Decision
422d
Days
Class 2
Risk

K021981 is an FDA 510(k) clearance for the IVENT 201 PORTABLE VENTILATOR. Classified as Continuous, Ventilator, Home Use (product code NOU), Class II - Special Controls.

Submitted by Versamed , Ltd. (Kadima, IL). The FDA issued a Cleared decision on August 13, 2003 after a review of 422 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Versamed , Ltd. devices

Submission Details

510(k) Number K021981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2002
Decision Date August 13, 2003
Days to Decision 422 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
283d slower than avg
Panel avg: 139d · This submission: 422d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code NOU Continuous, Ventilator, Home Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
Definition This Product Code Was Needed For The Home Use Indication. Cbk Is Not A Tracked Device And Nou Is A Tracked Device.
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.