Cleared Traditional

K041473 - VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM

K041473 is an FDA 510(k) clearance for VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), manufactured by Vortran Medical Technology 1, Inc.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K041473 · Vortran Medical Technology 1, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
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Jul 2004
Decision
43d
Days
Class 2
Risk

K041473 is an FDA 510(k) clearance for the VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Vortran Medical Technology 1, Inc. (Sacramento, US). The FDA issued a Cleared decision on July 15, 2004 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vortran Medical Technology 1, Inc. devices

FDA 510(k) Submission Details - K041473

510(k) Number K041473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2004
Decision Date July 15, 2004
Days to Decision 43 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
97d faster than avg
Panel avg: 140d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTL Device Classification - Class 2, Special Controls

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
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 - BTL Ventilator, Emergency, Powered (resuscitator)

All 78
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