Cleared Traditional

K250860 - BreatheBand (Model 1000)

K250860 is an FDA 510(k) clearance for BreatheBand (Model 1000), manufactured by Exemplar Medical, LLC. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K250860 · Exemplar Medical, LLC · Anesthesiology device
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Oct 2025
Decision
195d
Days
Class 2
Risk

K250860 is an FDA 510(k) clearance for the BreatheBand® (Model 1000). Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Exemplar Medical, LLC (Kansas City, US). The FDA issued a Cleared decision on October 2, 2025 after a review of 195 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5665 - 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 Exemplar Medical, LLC devices

FDA 510(k) Submission Details - K250860

510(k) Number K250860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2025
Decision Date October 02, 2025
Days to Decision 195 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
55d slower than avg
Panel avg: 140d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYI Device Classification - Class 2, Special Controls

Product Code BYI Percussor, Powered-electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5665
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 - BYI Percussor, Powered-electric

All 17
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