510(k) · Cleared
ClearedFreedomEdge (R) Syringe Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Repro-Medical System, Inc., Dba Koru Medical Systems · FRN Pump, Infusion
Cleared on Nov 9, 2021 as substantially equivalent to K162613 (Repro-Med Systems, Inc. Dba Rms Medical Products, 2017) after a 201-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Nov 9, 2021
- Review
- 201 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K933652 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK933652 Freedom 60 Syringe Infusion Pump System with Syringe Set & TubingRepro-Med Systems, Inc. · 1994 · Recalled
- 1 generation backK162613 Integrated Catch-up Freedom Syringe Driver Infusion SystemRepro-Med Systems, Inc. Dba Rms Medical Products · 2017
- This deviceK211206 FreedomEdge (R) Syringe Infusion SystemRepro-Medical System, Inc., Dba Koru Medical Systems · 2021
- Descendant · cites it directly · 1 of its ownK214045 FreedomEdge Syringe Infusion SystemRepro-Medical System, Inc., Dba Koru Medical Systems · 2022
- Descendant · 2 generations on · 0 of its ownK252015 FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision…Koru Medical Systems, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933652 | Freedom 60 Syringe Infusion Pump System with Syringe Set & Tubing | Repro-Med Systems, Inc. | 1994 | 1 |
| −1 | K162613 | Integrated Catch-up Freedom Syringe Driver Infusion System | Repro-Med Systems, Inc. Dba Rms Medical Products | 2017 | — |
| 0 (this device) | K211206 | FreedomEdge (R) Syringe Infusion System | Repro-Medical System, Inc., Dba Koru Medical Systems | 2021 | — |
| +1 | K214045 | FreedomEdge Syringe Infusion System | Repro-Medical System, Inc., Dba Koru Medical Systems | 2022 | — |
| +2 | K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate… | Koru Medical Systems, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
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 |
|---|---|---|---|
| * | K162613 | Integrated Catch-up Freedom Syringe Driver Infusion SystemSummary page 5…latory Class: II Product Code: FRN, FPA, PKP III. PREDICATE DEVICE Predicate Device: Integrated Catch-Up FREEDOM Syringe Driver Infusion System, K162613 Reference Device: KORU HIgH-Flo Super26™ Subcutaneous Safety Needle Set, K180843. IV. DEVICE DESCRIPTION ===… | 2017 |
| † | K180843 | HIgH-Flo Super26 Subcutaneous Needle Sets | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K214045 | FreedomEdge Syringe Infusion System | 2022 | 1 |
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 27 years and passes through 3 companies; a new generation was cleared every 23.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K214045 (Repro-Medical System, Inc., Dba Koru Medical Systems, 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K162613.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 FreedomEdge® Syringe Infusion System is indicated for the intravenous or subcutaneous infusion of medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The FreedomEdge® Syringe Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic…
Read the full statement (268 words)
The FreedomEdge® Syringe Infusion System is indicated for the intravenous or subcutaneous infusion of medications and fluids in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The FreedomEdge® Syringe 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: 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 Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration.
The FreedomEdge® Syringe Infusion System with the FreedomEdge® Syringe Driver 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 FreedomEdge® Syringe Infusion System consists of the following components:
• FreedomEdge® Syringe Driver
• Precision Flow Rate Tubing™
• HIgH-Flo Subcutaneous Safety Needle Sets™
• HIgH-Flo Super26™ Subcutaneous Needle Sets are specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®) Single-use pre-filled syringe for subcutaneous administration.
The FreedomEdge® Syringe Infusion System is indicated for use with the BD® 20 mL syringe (US Reference number: 302830), BD 30 mL syringe (US Reference number: 302832), and Hizentra® 20 mL single-use pre-filled syringe (NDC 442096-458-96).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211206: FreedomEdge (R) Syringe Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211206
Report an extraction error
Are you the manufacturer?
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