Cleared Traditional

K200076 - Breezing Med

K200076 is the FDA 510(k) clearance for Breezing Med by Tf Health Co.. It is a Class 2 Anesthesiology device (product code BZL) cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K200076 · Tf Health Co. · Anesthesiology device
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Sep 2020
Decision
255d
Days
Class 2
Risk

K200076 is an FDA 510(k) clearance for the Breezing Med. Classified as Computer, Oxygen-uptake (product code BZL), Class II - Special Controls.

Submitted by Tf Health Co. (Tempe, US). The FDA issued a Cleared decision on September 25, 2020 after a review of 255 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1730 - 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 Tf Health Co. devices

Submission Details

510(k) Number K200076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2020
Decision Date September 25, 2020
Days to Decision 255 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
115d slower than avg
Panel avg: 140d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZL Computer, Oxygen-uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1730
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

Nda Partners
Roberta (Bobbi) Druyor-Sanchez

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.

Regulatory Peers - BZL Computer, Oxygen-uptake

All 8
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