510(k) · Cleared
ClearedFreedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koru Medical Systems · FRN Pump, Infusion
Cleared on Nov 3, 2023 as substantially equivalent to K200176 (Repro-Med Systems, Inc. Dba Koru Medical Systems, 2021) after a 127-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Nov 3, 2023
- Review
- 127 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K933652 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK933652 Freedom 60 Syringe Infusion Pump System with Syringe Set & TubingRepro-Med Systems, Inc. · 1994 · Recalled
- 2 generations backK162613 Integrated Catch-up Freedom Syringe Driver Infusion SystemRepro-Med Systems, Inc. Dba Rms Medical Products · 2017
- 1 generation backK200176 FREEDOM Integrated Syringe Infusion SystemRepro-Med Systems, Inc. Dba Koru Medical Systems · 2021
- This deviceK231918 Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets…Koru Medical Systems · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933652 | Freedom 60 Syringe Infusion Pump System with Syringe Set & Tubing | Repro-Med Systems, Inc. | 1994 | 1 |
| −2 | K162613 | Integrated Catch-up Freedom Syringe Driver Infusion System | Repro-Med Systems, Inc. Dba Rms Medical Products | 2017 | — |
| −1 | K200176 | FREEDOM Integrated Syringe Infusion System | Repro-Med Systems, Inc. Dba Koru Medical Systems | 2021 | — |
| 0 (this device) | K231918 | Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow… | Koru Medical Systems | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K200176 | FREEDOM Integrated Syringe Infusion SystemSummary page 6…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code I K200176 FREEDOM Integrated Syringe Infusion System FRN Device Descripti… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K200176.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
The Freedom60 Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®)…
Read the full statement (247 words)
The Freedom60 Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Gammagard Liquid®, Immune Globulin Infusion (Human) 10% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by Grifols®) in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling.
The Freedom60 Infusion System with the Freedom60® Infusion Pump and Precision Flow Rate Tubing™, is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: ertapenem, meropenem, oxacillin, and tobramycin.
The Freedom60 Infusion System consists of the following devices:
- Freedom60® Infusion Pump
- Precision Flow Rate Tubing
- High-Flo Subcutaneous Needle Sets
- High-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins: Cutaquig®, Immune Globulin Subcutaneous (Human) 16.5% Solution (manufactured by Octapharma®); Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®)
The Freedom60 Infusion System is indicated for use with the following syringes:
* BD® 50 ml syringe
* Medline® 60 ml Syringe
* Hizentra® 50 ml Prefilled Syringe
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231918: Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231918
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026