Cleared Traditional

K984468 - VITAL PEP

K984468 is an FDA 510(k) clearance for VITAL PEP, manufactured by Vital Signs, Inc.. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K984468 · Vital Signs, Inc. · Anesthesiology device
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Jun 1999
Decision
167d
Days
Class 2
Risk

K984468 is an FDA 510(k) clearance for the VITAL PEP. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on June 1, 1999 after a review of 167 days - an extended review 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: 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 Vital Signs, Inc. devices

FDA 510(k) Submission Details - K984468

510(k) Number K984468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1998
Decision Date June 01, 1999
Days to Decision 167 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
27d slower than avg
Panel avg: 140d · This submission: 167d
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 72
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K984468.
ROADRUNNER, PEP THERAPY DEVICE
K991561 · Dhd Healthcare Corp. · Nov 1999
BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE
K991300 · Dhd Healthcare Corp. · Jul 1999
RC CORNET, MODEL #44F50
K983308 · Pari Holding Co. · Jun 1999
THERAPEP
K983467 · Dhd Healthcare Corp. · Apr 1999
MINI-CISER
K974848 · Hougen Mfg., Inc. · Aug 1998
THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER
K972824 · Pn Medical · Apr 1998