Cleared Traditional

K020641 - SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001

K020641 is an FDA 510(k) clearance for SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001, manufactured by Worldwide Medical Technologies, LLC. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K020641 · Worldwide Medical Technologies, LLC · Anesthesiology device
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Oct 2002
Decision
244d
Days
Class 2
Risk

K020641 is an FDA 510(k) clearance for the SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Worldwide Medical Technologies, LLC (Waycross, US). The FDA issued a Cleared decision on October 29, 2002 after a review of 244 days - an extended review 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: 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 Worldwide Medical Technologies, LLC devices

FDA 510(k) Submission Details - K020641

510(k) Number K020641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2002
Decision Date October 29, 2002
Days to Decision 244 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 140d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
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 - BZD Ventilator, Non-continuous (respirator)

All 267
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K020641.
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K012554 · Respironics, Inc. · Jan 2002