Cleared Traditional

K160837 - MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM

K160837 is an FDA 510(k) clearance for MEDINET INCENTIVE SPIROMETERS - RESPIPR..., manufactured by Medinet Srl. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K160837 · Medinet Srl · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
335d
Days
Class 2
Risk

K160837 is an FDA 510(k) clearance for the MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Medinet Srl (Milano, IT). The FDA issued a Cleared decision on February 23, 2017 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5690 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K160837

510(k) Number K160837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2016
Decision Date February 23, 2017
Days to Decision 335 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
195d slower than avg
Panel avg: 140d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BWF Device Classification - Class 2, Special Controls

Product Code BWF Spirometer, Therapeutic (incentive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5690
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

Isemed S.R.L.
MAURIZIO PANTALEONI

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 - BWF Spirometer, Therapeutic (incentive)

All 83
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K160837.
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O-PEP
K150044 · Pari Respiratory Equipment, Inc. · May 2016
K160837 · MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM
Download PDF FDA Summary Medinet Srl