Cleared Traditional

K001318 - CPAP SYSTEM, MODEL 102001

K001318 is an FDA 510(k) clearance for CPAP SYSTEM, manufactured by Sims Portex, Inc.. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K001318 · Sims Portex, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
85d
Days
Class 2
Risk

K001318 is an FDA 510(k) clearance for the CPAP SYSTEM, MODEL 102001. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Sims Portex, Inc. (Keene, US). The FDA issued a Cleared decision on July 20, 2000 after a review of 85 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K001318

510(k) Number K001318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2000
Decision Date July 20, 2000
Days to Decision 85 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
55d faster than avg
Panel avg: 140d · This submission: 85d
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 72
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K001318.
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K001318 · CPAP SYSTEM, MODEL 102001
Download PDF FDA Summary Sims Portex, Inc.