Cleared Traditional

K963558 - CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR

K963558 is an FDA 510(k) clearance for CPI MODEL 6260, manufactured by Contemporary Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code JCX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K963558 · Contemporary Products, Inc. · General & Plastic Surgery device
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Dec 1996
Decision
90d
Days
Class 2
Risk

K963558 is an FDA 510(k) clearance for the CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR. Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by Contemporary Products, Inc. (Portland, US). The FDA issued a Cleared decision on December 4, 1996 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K963558

510(k) Number K963558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1996
Decision Date December 04, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JCX Device Classification - Class 2, Special Controls

Product Code JCX Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - JCX Apparatus, Suction, Ward Use, Portable, Ac-powered

All 64
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K963558 · CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR
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