Cleared Traditional

K050542 - MARIAN INFANT FEEDING TUBE (GUARDIANPIC...

K050542 is an FDA 510(k) clearance for MARIAN INFANT FEEDING TUBE (GUARDIANPIC..., manufactured by Marian Medical, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K050542 · Marian Medical, Inc. · General Hospital
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Jul 2005
Decision
146d
Days
Class 2
Risk

K050542 is an FDA 510(k) clearance for the MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Marian Medical, Inc. (Louisville, US). The FDA issued a Cleared decision on July 26, 2005 after a review of 146 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - 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 Marian Medical, Inc. devices

FDA 510(k) Submission Details - K050542

510(k) Number K050542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2005
Decision Date July 26, 2005
Days to Decision 146 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 129d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJS Device Classification - Class 2, Special Controls

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 191
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K050542.
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VYGON NUTRILINE CATHETERS
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K041849 · Cook, Inc. · Jul 2005
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K051417 · C.R. Bard, Inc. · Jun 2005