Cleared Traditional

K213754 - SpiroHome Personal, SpiroHome Clinic (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213754 · Inofab Saglik Teknolojileri A.S · Anesthesiology device
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Jun 2023
Decision
559d
Days
Class 2
Risk

K213754 is an FDA 510(k) clearance for the SpiroHome Personal, SpiroHome Clinic. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Inofab Saglik Teknolojileri A.S (Cankaya, Ankara, TR). The FDA issued a Cleared decision on June 12, 2023 after a review of 559 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. 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 Inofab Saglik Teknolojileri A.S devices

Submission Details

510(k) Number K213754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2021
Decision Date June 12, 2023
Days to Decision 559 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
420d slower than avg
Panel avg: 139d · This submission: 559d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Arazy Group Consultants, Inc.
Ray Kelly

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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