Cleared Traditional

K981668 - SMARTVENT 201 PORTABLE VENTILATOR

K981668 is an FDA 510(k) clearance for SMARTVENT 201 PORTABLE VENTILATOR, manufactured by Versamed , Ltd.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K981668 · Versamed , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
331d
Days
Class 2
Risk

K981668 is an FDA 510(k) clearance for the SMARTVENT 201 PORTABLE VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Versamed , Ltd. (Ra'Ananna 43373, IL). The FDA issued a Cleared decision on April 7, 1999 after a review of 331 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 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. Elevated predicate reliance profile. 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 Versamed , Ltd. devices

FDA 510(k) Submission Details - K981668

510(k) Number K981668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1998
Decision Date April 07, 1999
Days to Decision 331 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
191d slower than avg
Panel avg: 140d · This submission: 331d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 355
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K981668.
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