Cleared Traditional

K954422 - PER-Q-CATH MID-LINE

K954422 is the FDA 510(k) clearance for PER-Q-CATH MID-LINE by Gesco Intl., Inc.. It is a Class 2 General Hospital device (product code LJS) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K954422 · Gesco Intl., Inc. · General Hospital
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Dec 1995
Decision
85d
Days
Class 2
Risk

K954422 is an FDA 510(k) clearance for the PER-Q-CATH MID-LINE. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Gesco Intl., Inc. (Woburn, US). The FDA issued a Cleared decision on December 15, 1995 after a review of 85 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 Gesco Intl., Inc. devices

Submission Details

510(k) Number K954422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1995
Decision Date December 15, 1995
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
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
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K954422.
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PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICES
K954104 · C.R. Bard, Inc. · Nov 1995
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K930129 · Arrow Intl., Inc. · Mar 1994
NEEDLELESS INJECTION CANNULA
K923653 · Arrow Intl., Inc. · May 1993