Cleared Traditional

K933050 - CHANGES TO PROTECTIV(TM) & JELCO(TM) WI...

K933050 is an FDA 510(k) clearance for CHANGES TO PROTECTIV(TM) & JELCO(TM) WI..., manufactured by Critikon Company, LLC. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K933050 · Critikon Company, LLC · General Hospital
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Dec 1993
Decision
208d
Days
Class 2
Risk

K933050 is an FDA 510(k) clearance for the CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Critikon Company, LLC (Tampa, US). The FDA issued a Cleared decision on December 14, 1993 after a review of 208 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Critikon Company, LLC devices

FDA 510(k) Submission Details - K933050

510(k) Number K933050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1993
Decision Date December 14, 1993
Days to Decision 208 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 129d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 Hospital devices follow this clearance model.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 302
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K933050.
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