Cleared Traditional

K160636 - iPEP System and vPEP

K160636 is the FDA 510(k) clearance for iPEP System and vPEP by D R Burton Healthcare, LLC. It is a Class 2 Anesthesiology device (product code BWF) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K160636 · D R Burton Healthcare, LLC · Anesthesiology device
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Aug 2016
Decision
149d
Days
Class 2
Risk

K160636 is an FDA 510(k) clearance for the iPEP System and vPEP. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by D R Burton Healthcare, LLC (Farmville, US). The FDA issued a Cleared decision on August 3, 2016 after a review of 149 days - within the typical 510(k) review window.

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. 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 D R Burton Healthcare, LLC devices

Submission Details

510(k) Number K160636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2016
Decision Date August 03, 2016
Days to Decision 149 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
9d slower than avg
Panel avg: 140d · This submission: 149d
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 29
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K160636.
Combined Aerobika OPEP and VersaPAP device
K183108 · Trudell Medical International · Aug 2019
Hudson RCI Voldyne Volumetric Exerciser
K182847 · Teleflexmedical, Inc. · Jul 2019
VersaPAP Positive Airway Pressure (PAP) Device
K173918 · Trudell Medical International · Aug 2018
VITAL PEP
K984468 · Vital Signs, Inc. · Jun 1999
AIRLIFE ELECTRONIC INCENTIVE SPIROMETER
K851334 · American Pharmaseal Div. Ahsc · Aug 1985
ELECATH INFANT ARTERIAL & VENOUS CANNU
K842369 · Electro-Catheter Corp. · Aug 1984