Cleared Traditional

K910315 - PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K910315 · Sorex Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
57d faster than avg
Panel avg: 128d · 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 301
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K910315.
Neonav ECG Tip Location System
K260929 · Navi Medical Technologies · Apr 2026
BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology
K252373 · Spectrum Vascular · Dec 2025
PM2™ System with ECGuide™ Connector
K252792 · Piccolo Medical, Inc. · Nov 2025
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)
K243458 · Access Vascular, Inc. · Aug 2025
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM)
K251212 · Access Vascular, Inc. · Jul 2025
PM2+ System and SmartPICC Stylet
K243484 · Piccolo Medical, Inc. · May 2025