Cleared Traditional

K910315 - PICC INSERTION KIT/P.I.C. & PICC EXCHAN...

K910315 is the FDA 510(k) clearance for PICC INSERTION KIT/P.I.C. & PICC EXCHAN... by Sorex Medical. It is a Class 2 General Hospital device (product code LJS) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K910315 · Sorex Medical · General Hospital
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Apr 1991
Decision
71d
Days
Class 2
Risk

K910315 is an FDA 510(k) clearance for the PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Sorex Medical (Salt Lake City, US). The FDA issued a Cleared decision on April 5, 1991 after a review of 71 days - a notably fast clearance cycle.

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

View all Sorex Medical devices

Submission Details

510(k) Number K910315 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received January 24, 1991
Decision Date April 05, 1991
Days to Decision 71 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 129d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 106
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