Cleared Traditional

K953511 - KENDALL SHERIDAN CPAP SYSTEM

K953511 is an FDA 510(k) clearance for KENDALL SHERIDAN CPAP SYSTEM, manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K953511 · Kendall Healthcare Products Co. Div.Of Tyco Health · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
92d
Days
Class 2
Risk

K953511 is an FDA 510(k) clearance for the KENDALL SHERIDAN CPAP SYSTEM. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on October 26, 1995 after a review of 92 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K953511

510(k) Number K953511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received July 26, 1995
Decision Date October 26, 1995
Days to Decision 92 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 140d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYE Device Classification - Class 2, Special Controls

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 44
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K953511.
EMS PEEP VALVES- ADJUSTABLE
K983920 · Engineered Medical Systems · Jan 1999
REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142
K963347 · Instrumentation Industries, Inc. · Mar 1997
SIMS CPAP SYSTEM
K953485 · Smiths Industries Medical Systems, Inc. · Oct 1995
SYSTEM 22 VALVE
K950397 · Turnkey Intergration USA, Inc. · Apr 1995
SINGLE USE MANUAL RESUSCITATOR PEEP VALVE
K932799 · Engineered Medical Systems · Sep 1993
AMBU SINGLE PATIENT USE PEEP VALVE
K923976 · Ambu, Inc. · Jan 1993