Cleared Traditional

K140799 - CELERITY SYSYEM

K140799 is an FDA 510(k) clearance for CELERITY SYSYEM, manufactured by Medcomp (Medical Components, Inc.). The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K140799 · Medcomp (Medical Components, Inc.) · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
74d
Days
Class 2
Risk

K140799 is an FDA 510(k) clearance for the CELERITY SYSYEM. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Medcomp (Medical Components, Inc.) (Marlborough, US). The FDA issued a Cleared decision on June 13, 2014 after a review of 74 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 Medcomp (Medical Components, Inc.) devices

FDA 510(k) Submission Details - K140799

510(k) Number K140799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2014
Decision Date June 13, 2014
Days to Decision 74 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 129d · This submission: 74d
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 194
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K140799.
Sherlock 3CG Tip Positioning System Stylet
K142267 · C.R. Bard, Inc. · Oct 2014
PICC Maximal Barrier Nursing Kit
K142616 · Navilyst Medical, Inc. · Oct 2014
PRO-PICC WITH VALVE TECHNOLOGY
K141633 · Medical Components, Inc. · Sep 2014
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
K140345 · C.R. Bard, Inc. · Mar 2014
NMI PICC IV
K140266 · Navilyst Medical, Inc. · Mar 2014
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
K133634 · Cook, Inc. · Dec 2013