Cleared Traditional

K141546 - VITALOGRAPH MODEL 7000 SPIROTRAC

K141546 is an FDA 510(k) clearance for VITALOGRAPH MODEL 7000 SPIROTRAC, manufactured by Vitalograph (Ireland) , Ltd.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K141546 · Vitalograph (Ireland) , Ltd. · Anesthesiology device
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Sep 2014
Decision
85d
Days
Class 2
Risk

K141546 is an FDA 510(k) clearance for the VITALOGRAPH MODEL 7000 SPIROTRAC. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Vitalograph (Ireland) , Ltd. (Ennis, Co. Clare, IE). The FDA issued a Cleared decision on September 3, 2014 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - 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 Vitalograph (Ireland) , Ltd. devices

FDA 510(k) Submission Details - K141546

510(k) Number K141546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2014
Decision Date September 03, 2014
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

BZG Device Classification - Class 2, Special Controls

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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