Cleared Traditional

K935145 - CYPERFLO PERIPHERALLY INSERTED CATHETER

K935145 is an FDA 510(k) clearance for CYPERFLO PERIPHERALLY INSERTED CATHETER, manufactured by Cyex Medical Technologies, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 499-day FDA review.

K935145 · Cyex Medical Technologies, Inc. · General Hospital
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Mar 1995
Decision
499d
Days
Class 2
Risk

K935145 is an FDA 510(k) clearance for the CYPERFLO PERIPHERALLY INSERTED CATHETER. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Cyex Medical Technologies, Inc. (Markham, Ontario, CA). The FDA issued a Cleared decision on March 9, 1995 after a review of 499 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Cyex Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K935145

510(k) Number K935145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1993
Decision Date March 09, 1995
Days to Decision 499 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
370d slower than avg
Panel avg: 129d · This submission: 499d
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 275
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K935145.
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STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS
K946250 · Strato Medical Corp. · May 1995
VASCULAR ACCESS CATHETER ACCESSORIES
K935380 · Bard Access Systems, Inc. · Feb 1995
PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH
K932198 · Pharmacia Deltec, Inc. · May 1994
PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS
K932211 · Pharmacia Deltec, Inc. · May 1994