Cleared Traditional

K972042 - PARI PEP THERAPY SYSTEM

K972042 is an FDA 510(k) clearance for PARI PEP THERAPY SYSTEM, manufactured by Pari Holding Co.. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K972042 · Pari Holding Co. · Anesthesiology device
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Aug 1997
Decision
64d
Days
Class 2
Risk

K972042 is an FDA 510(k) clearance for the PARI PEP THERAPY SYSTEM. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Pari Holding Co. (Midlothian, US). The FDA issued a Cleared decision on August 5, 1997 after a review of 64 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pari Holding Co. devices

FDA 510(k) Submission Details - K972042

510(k) Number K972042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1997
Decision Date August 05, 1997
Days to Decision 64 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 140d · This submission: 64d
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 Peers - BWF Spirometer, Therapeutic (incentive)

All 45
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K972042.
INCENTIVE SPIROMETER
K000314 · Engineered Medical Systems · Apr 2000
VITAL PEP
K984468 · Vital Signs, Inc. · Jun 1999
THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER
K972824 · Pn Medical · Apr 1998
DHD EMERALD PRODUCT
K970596 · Dhd Diemolding Healthcare Div. · May 1997
TVS II ELECTRONIC INCENTIVE SPIROMETER
K910138 · Monaghan Medical Corp. · Mar 1991
AEROSOL INHALATION MONITOR
K893665 · Vitalograph , Ltd. · Aug 1989