Cleared Traditional

K901728 - ONE-LUNG CPAP DEVICE

K901728 is the FDA 510(k) clearance for ONE-LUNG CPAP DEVICE by Vital Signs, Inc.. It is a Class 2 Anesthesiology device (product code BYE) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K901728 · Vital Signs, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
120d
Days
Class 2
Risk

K901728 is an FDA 510(k) clearance for the ONE-LUNG CPAP DEVICE. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on August 14, 1990 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5965 - 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

Submission Details

510(k) Number K901728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1990
Decision Date August 14, 1990
Days to Decision 120 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 140d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BYE Attachment, Breathing, Positive End Expiratory Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5965
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 - BYE Attachment, Breathing, Positive End Expiratory Pressure

All 35
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K901728.
COMPANION 318 NASAL CPAP SYSTEM
K903764 · Puritan Bennett Corp. · Sep 1990
PEEP VALVE
K902062 · Hudson Oxygen Therapy Sales Co. · Sep 1990
PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE
K903125 · Puritan Bennett Corp. · Sep 1990
RESPIRONICS' REMSTAR(TM) SLEEPEASY
K900113 · Respironics, Inc. · Mar 1990
AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA.
K900164 · Puritan Bennett Corp. · Jan 1990
DEVILBISS MODEL 7351 SERIES
K894424 · Devilbiss Health Care, Inc. · Sep 1989