510(k) · Cleared
ClearedIntegrated Catch-up Freedom Syringe Driver Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Repro-Med Systems, Inc. Dba Rms Medical Products · FRN Pump, Infusion
Cleared on Aug 31, 2017 as substantially equivalent to K933652 (Repro-Med Systems, Inc., 1994) after a 346-day review. Its family tree reaches back 1 generation to 1994. 6 later devices descend from it.
- Decided
- Aug 31, 2017
- Review
- 346 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933652 (1994). 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK933652 Freedom 60 Syringe Infusion Pump System with Syringe Set & TubingRepro-Med Systems, Inc. · 1994 · Recalled
- This deviceK162613 Integrated Catch-up Freedom Syringe Driver Infusion SystemRepro-Med Systems, Inc. Dba Rms Medical Products · 2017
- Descendant · cites it directly · 2 of its ownK200176 FREEDOM Integrated Syringe Infusion SystemRepro-Med Systems, Inc. Dba Koru Medical Systems · 2021
- Descendant · cites it directly · 2 of its ownK211206 FreedomEdge (R) Syringe Infusion SystemRepro-Medical System, Inc., Dba Koru Medical Systems · 2021
- Descendant · 2 generations on · 1 of its ownK214045 FreedomEdge Syringe Infusion SystemRepro-Medical System, Inc., Dba Koru Medical Systems · 2022
- Descendant · 3 generations on · 0 of its ownK252015 FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision…Koru Medical Systems, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK232328 Insignis™ Syringe Infusion SystemInnovative Health Sciences, LLC · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K200176FREEDOM Integrated Syringe Infusion SystemRepro-Med Systems, Inc. Dba Koru Medical Systems · 2021 · cites it directly2descendants
- K211206FreedomEdge (R) Syringe Infusion SystemRepro-Medical System, Inc., Dba Koru Medical Systems · 2021 · cites it directly2descendants
- K214045FreedomEdge Syringe Infusion SystemRepro-Medical System, Inc., Dba Koru Medical Systems · 2022 · 2 generations on1descendant
- K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc. · 2026 · 3 generations on0descendants
- K232328Insignis™ Syringe Infusion SystemInnovative Health Sciences, LLC · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933652 | Freedom 60 Syringe Infusion Pump System with Syringe Set & Tubing | Repro-Med Systems, Inc. | 1994 | 1 |
| 0 (this device) | 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 | — |
| +1 | K211206 | FreedomEdge (R) Syringe Infusion System | Repro-Medical System, Inc., Dba Koru Medical Systems | 2021 | — |
| +2 | K214045 | FreedomEdge Syringe Infusion System | Repro-Medical System, Inc., Dba Koru Medical Systems | 2022 | — |
| +3 | K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate… | Koru Medical Systems, Inc. | 2026 | — |
| +2 | K232328 | Insignis™ Syringe Infusion System | Innovative Health Sciences, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K933652 | Freedom 60 Syringe Infusion Pump System with Syringe Set & TubingSummary page 4…ml (model no. 301033) syringe. The Freedom60 Syringe Infusion System is indicated for use with the BD 60 ml syringe (model no. 309653). Primary Predicate Device K933652, Freedom60 Syringe Infusion System Page 1 of 8 Reference Device(s)… | 1994 |
| † | K161906 | SCIg60 Infuser | 2016 |
| † | K102512 | RMS Subcutaneous Needle Set | 2011 |
| † | K122404 | Model Number: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614… | 2013 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Integrated Catch-Up Freedom Syringe Driver Infusion System (ICFSDIS), which includes the FREEDOM60® and FreedomEdge® syringe pumps, 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 ICFSDIS is specifically indicated for the subcutaneous infusion of the following human plasma-derived…
Read the full statement (173 words)
The Integrated Catch-Up Freedom Syringe Driver Infusion System (ICFSDIS), which includes the FREEDOM60® and FreedomEdge® syringe pumps, 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 ICFSDIS is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Hizentra, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring); Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Shire); and Cuvitru Immune Globulin Infusion (Human) 20% (manufactured by Shire). The ICFSDIS is specifically indicated for the intravenous infusion of the following antibiotics when used according to the FDA approved drug product labeling: meropenem, ertapenem, oxacillin, and tobramycin.
The FreedomEdge® Syringe Infusion System is indicated for use with the BD 20 ml (model no. 302830/301031) or BD 30 ml (model no. 301033) syringe. The Freedom60 Syringe Infusion System is indicated for use with the BD 60 ml syringe (model no. 309653).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162613: Integrated Catch-up Freedom Syringe Driver 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/K162613
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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