Cleared Traditional

K161295 - MiniBox + (FDA 510(k) Clearance)

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

K161295 · Pulmone Advanced Medical Devices, Ltd. · Anesthesiology device
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Oct 2016
Decision
165d
Days
Class 2
Risk

K161295 is an FDA 510(k) clearance for the MiniBox +. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Pulmone Advanced Medical Devices, Ltd. (Ra’Ananna, IL). The FDA issued a Cleared decision on October 21, 2016 after a review of 165 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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 Pulmone Advanced Medical Devices, Ltd. devices

Submission Details

510(k) Number K161295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2016
Decision Date October 21, 2016
Days to Decision 165 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
26d slower than avg
Panel avg: 139d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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.