Cleared Traditional

K960587 - CPROTECTOR 2000

K960587 is the FDA 510(k) clearance for CPROTECTOR 2000 by Certified Safety Mfg., Inc.. It is a Class 2 Anesthesiology device (product code CBP) cleared through the Traditional 510(k) pathway after a 525-day FDA review.

K960587 · Certified Safety Mfg., Inc. · Anesthesiology device
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Jul 1997
Decision
525d
Days
Class 2
Risk

K960587 is an FDA 510(k) clearance for the CPROTECTOR 2000. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Certified Safety Mfg., Inc. (Kansas City, US). The FDA issued a Cleared decision on July 21, 1997 after a review of 525 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Certified Safety Mfg., Inc. devices

Submission Details

510(k) Number K960587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1996
Decision Date July 21, 1997
Days to Decision 525 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
385d slower than avg
Panel avg: 140d · This submission: 525d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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 - CBP Valve, Non-rebreathing

All 8
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