Cleared Traditional

K953485 - SIMS CPAP SYSTEM

K953485 is an FDA 510(k) clearance for SIMS CPAP SYSTEM, manufactured by Smiths Industries Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K953485 · Smiths Industries Medical Systems, Inc. · Anesthesiology device
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Oct 1995
Decision
94d
Days
Class 2
Risk

K953485 is an FDA 510(k) clearance for the SIMS CPAP SYSTEM. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Smiths Industries Medical Systems, Inc. (Keene, US). The FDA issued a Cleared decision on October 26, 1995 after a review of 94 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 Smiths Industries Medical Systems, Inc. devices

FDA 510(k) Submission Details - K953485

510(k) Number K953485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1995
Decision Date October 26, 1995
Days to Decision 94 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
46d faster than avg
Panel avg: 140d · This submission: 94d
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 K953485.
EMS PEEP VALVES- ADJUSTABLE
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REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142
K963347 · Instrumentation Industries, Inc. · Mar 1997
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K953511 · Kendall Healthcare Products Co. Div.Of Tyco Health · 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