Cleared Traditional

K121587 - BREATH SHAKE (FDA 510(k) Clearance)

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

K121587 · Cheen Houng Ent. Co. , Ltd. · Anesthesiology device
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Nov 2013
Decision
540d
Days
Class 2
Risk

K121587 is an FDA 510(k) clearance for the BREATH SHAKE. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Cheen Houng Ent. Co. , Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on November 22, 2013 after a review of 540 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Cheen Houng Ent. Co. , Ltd. devices

Submission Details

510(k) Number K121587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2012
Decision Date November 22, 2013
Days to Decision 540 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
401d slower than avg
Panel avg: 139d · This submission: 540d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 57
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