510(k) · Cleared
ClearedInsignis™ Syringe Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Health Sciences, LLC · FPA Set, Administration, Intravascular
Cleared on Mar 1, 2024 as substantially equivalent to K200176 (Repro-Med Systems, Inc. Dba Koru Medical Systems, 2021) after a 211-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Mar 1, 2024
- Review
- 211 days
- Class
- Class II
- Product code
- FPA
- 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 deviceK232328 Insignis™ Syringe Infusion SystemInnovative Health Sciences, LLC · 2024
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) | K232328 | Insignis™ Syringe Infusion System | Innovative Health Sciences, LLC | 2024 | — |
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 FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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…utaneous Administration Set The Insignis Syringe Driver is indicated for use with the BD® 50 ml syringe (US Reference number 309653). 8. Predicate Device • K200176, FREEDOM Integrated Syringe Infusion System 9. Reference Devices • K222087 SCIg60 Infusion System • K202279 Insignis… | 2021 |
| † | K222087 | SCIg60 Infusion System | 2022 |
| † | K202279 | Insignis Subcutaneous Needle Sets | 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 30 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 FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The Insignis™ 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®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by…
Read the full statement (213 words)
The Insignis™ 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®); 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 system is intended for use by clinicians and lay users. It is intended for use in adults and in adolescents ages 13-21. For adolescents, it is to be operated under the supervision of an adult after instruction is provided by a healthcare provider.
The Insignis ™ Syringe Infusion System with the Insignis Syringe Driver and Intravenous Controller, is specifically indicated for the intravenous infusion of fluids such as 0.9% Sodium Chloride (normal saline) and dextrose solutions, and the following antibiotics when used according to the FDA approved drug product labeling: vancomycin, ertapenem, meropenem, oxacillin, and tobramycin.
The Insignis™ Syringe Infusion System consists of the following components:
• Insignis Syringe Driver
• Intravenous Controller
• OneSett Subcutaneous Administration Set
The Insignis Syringe Driver is indicated for use with the BD® 50 ml syringe (US Reference number 309653)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232328 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232328: Insignis™ 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/K232328
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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