Cleared Traditional

O-PEP (K150044) - FDA 510(k) Clearance

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

K150044 · Pari Respiratory Equipment, Inc. · Anesthesiology device
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May 2016
Decision
501d
Days
Class 2
Risk

K150044 is an FDA 510(k) clearance for the O-PEP. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Pari Respiratory Equipment, Inc. (Midlothian, US). The FDA issued a Cleared decision on May 27, 2016 after a review of 501 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: 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 Pari Respiratory Equipment, Inc. devices

Submission Details

510(k) Number K150044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2015
Decision Date May 27, 2016
Days to Decision 501 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
361d slower than avg
Panel avg: 140d · This submission: 501d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - BWF Spirometer, Therapeutic (incentive)

All 14
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K150044.
Combined Aerobika OPEP and VersaPAP device
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ARGYLE TRU-VOL
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CALCULATOR, WITH CHARGER
K781838 · C.R. Bard, Inc. · Nov 1978
RESPIRATORY EXERCISOR, VOLUME PULSE
K781669 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1978