Cleared Traditional

K162613 - Integrated Catch-up Freedom Syringe Dri...

K162613 is an FDA 510(k) clearance for Integrated Catch-up Freedom Syringe Dri..., manufactured by Repro-Med Systems, Inc. Dba Rms Medical Products. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 346-day FDA review.

K162613 · Repro-Med Systems, Inc. Dba Rms Medical Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
346d
Days
Class 2
Risk

K162613 is an FDA 510(k) clearance for the Integrated Catch-up Freedom Syringe Driver Infusion System. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Repro-Med Systems, Inc. Dba Rms Medical Products (New York, US). The FDA issued a Cleared decision on August 31, 2017 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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. Elevated predicate reliance profile. 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 Repro-Med Systems, Inc. Dba Rms Medical Products devices

FDA 510(k) Submission Details - K162613

510(k) Number K162613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2016
Decision Date August 31, 2017
Days to Decision 346 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
217d slower than avg
Panel avg: 129d · This submission: 346d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 481
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K162613.
Power Infuser
K172653 · ZOLL Medical Corporation · Jul 2018
Perfusor® Space Syringe Infusion Pump System
K172831 · B.Braun Medical, Inc. · Jun 2018
Spectrum IQ Infusion System, Dose IQ Safety Software
K173084 · Baxter Healthcare Corporation · May 2018
Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module
K161469 · Hospira, Inc. · Mar 2017
Infusomat Space Volumetric Infusion Pump
K142596 · B.Braun Medical, Inc. · Jun 2015
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE
K141789 · Hospira, Inc. · Jan 2015