Cleared Traditional

K171931 - Celerity ECG Cable Accessory Pack

K171931 is an FDA 510(k) clearance for Celerity ECG Cable Accessory Pack, 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 120-day FDA review.

K171931 · Medcomp (Medical Components, Inc.) · General Hospital
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Oct 2017
Decision
120d
Days
Class 2
Risk

K171931 is an FDA 510(k) clearance for the Celerity ECG Cable Accessory Pack. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Medcomp (Medical Components, Inc.) (Harleysville, US). The FDA issued a Cleared decision on October 26, 2017 after a review of 120 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Medcomp (Medical Components, Inc.) devices

FDA 510(k) Submission Details - K171931

510(k) Number K171931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2017
Decision Date October 26, 2017
Days to Decision 120 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
9d faster than avg
Panel avg: 129d · This submission: 120d
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 K171931.
Vygon PICCs
K172899 · Vygon USA · Feb 2018
Silicone Peripherally Inserted Central Venous Catheter Set/Tray
K171994 · Cook Incorporated · Feb 2018
HydroPICC
K172885 · Access Vascular, Inc. · Feb 2018
Sherlock 3CG Tip Positioning System Stylet
K172397 · C.R. Bard, Inc. · Sep 2017
PowerPICC Provena Catheters with SOLO Valve Technology
K162441 · C.R. Bard, Inc. · Apr 2017
PICC Maximal Barrier Nursing Kit
K163452 · Navilyst Medical, Inc. · Feb 2017