Cleared Traditional

K231918 - Freedom60 Infusion Pump

Also marketed or referenced as:
High-Flo Subcutaneous Needle Sets Precision Flow Rate Tubing High-Flo Super26 Subcutaneous Needle Sets Freedom60 Pre-Filled Syringe Adapter

K231918 is an FDA 510(k) clearance for Freedom60 Infusion Pump, manufactured by Koru Medical Systems. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K231918 · Koru Medical Systems · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
127d
Days
Class 2
Risk

K231918 is an FDA 510(k) clearance for the Freedom60 Infusion Pump. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Koru Medical Systems (Mahwah, US). The FDA issued a Cleared decision on November 3, 2023 after a review of 127 days - within the typical 510(k) review window.

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. 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 Koru Medical Systems devices

FDA 510(k) Submission Details - K231918

510(k) Number K231918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2023
Decision Date November 03, 2023
Days to Decision 127 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 129d · This submission: 127d
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 459
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K231918.
Novum IQ Syringe Pump (40800BAXUS)
K242390 · Baxter Healthcare Corporation · Sep 2024
Curlin 8000 Ambulatory Infusion System
K232793 · Zevex, Inc. · May 2024
Novum IQ Large Volume Pump
K211122 · Baxter Healthcare Corporation · Mar 2024
SAFIRA
K230083 · Medovate Limited · Oct 2023
Plum Duo™ Infusion System
K223607 · Icu Medical, Inc. · Aug 2023
BD Alaris System with Guardrails Suite MX v12.1.2
K211218 · Carefusion 303, Inc. · Jul 2023