510(k) · Cleared
ClearedDEKA Infusion System, DEKA Administration Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deka Research and Development · LDR Controller, Infusion, Intravascular, Electronic
Cleared on Mar 1, 2024 as substantially equivalent to K153760 (DEKA Research & Development, 2016) and 1 other predicate after a 211-day review. Its family tree reaches back 3 generations to 1983. 1 later device descends from it.
- Decided
- Mar 1, 2024
- Review
- 211 days
- Class
- Class II
- Product code
- LDR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K832284 (1983). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK832284 Solution Admin. Set 2C9096 W/10 PVCTravenol Laboratories, S.A. · 1983 · Recalled
- 2 generations backK981792 Solution Administration SetBaxter Healthcare Corp · 1998 · Recalled
- 1 generation backK120685 Zyno Medical Administration SetZyno Medical, LLC · 2012
- This deviceK232316 DEKA Infusion System, DEKA Administration SetDeka Research and Development · 2024
- Descendant · cites it directly · 0 of its ownK242693 DEKA Infusion System, DEKA Administration SetDeka Research and Development Corporation · 2024
Most influential descendants
Showing 1 of 1 · See all- K242693DEKA Infusion System, DEKA Administration SetDeka Research and Development Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K832284 | Solution Admin. Set 2C9096 W/10 PVC | Travenol Laboratories, S.A. | 1983 | 2 |
| −2 | K981792 | Solution Administration Set | Baxter Healthcare Corp | 1998 | 5 |
| −1 | K120685 | Zyno Medical Administration Set | Zyno Medical, LLC | 2012 | — |
| 0 (this device) | K232316 | DEKA Infusion System, DEKA Administration Set | Deka Research and Development | 2024 | — |
| +1 | K242693 | DEKA Infusion System, DEKA Administration Set | Deka Research and Development Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1997 | 1 | 0 |
| 2006 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 LDR? 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 LDR device
- #1 K242693 DEKA Infusion System, DEKA Administration Setscore 9.0 · 4 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K153760 | Volumetric Infusion ControllerSummary page 6…nfusion System The DEKA Infusion System is substantially equivalent to the DEKA Volumetric Infusion Controller, which was previously cleared under premarket application K153760 on October 3, 2016. The DEKA Infusion System has a VTBI functionality that is substantially equivalent to that of the reference d… | 2016 |
| * | K120685 | Zyno Medical Administration SetSummary page 6…inistration Set The DEKA Administration Set is substantially equivalent to the Zyno Medical Administration Set, which was previously cleared under premarket application K120685 on September 7, 2012. Device Description DEKA Infusion System The DEKA Infusion System, comprised of the DEKA Infusion Controll… | 2012 |
| † | K192860 | Sapphire Infusion Pump, Sapphire administration sets | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242693 | DEKA Infusion System, DEKA Administration Set | 2024 | 0 |
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 41 years and passes through 4 companies; a new generation was cleared every 14.1 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K242693 (Deka Research and Development Corporation, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LDR devicesLDR Controller, Infusion, Intravascular, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · LDR
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LDR
Too few LDR 510(k)s in any year since 2007 to give a median.
Recalls per year · LDR
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDR
3in 2023
MAUDE reports naming product code LDR, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 4 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 0 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DEKA Infusion System is indicated for continuous delivery of general maintenance fluids and supported antibiotics to adult patients through a peripheral intravenous (IV) site under the supervision of a qualified clinician. The DEKA Administration Set is indicated for gravity administration of general maintenance fluids and supported antibiotics approved for peripheral intravenous (IV) infusion to adult patients under the supervision of a qualified…
Read the full statement (116 words)
The DEKA Infusion System is indicated for continuous delivery of general maintenance fluids and supported antibiotics to adult patients through a peripheral intravenous (IV) site under the supervision of a qualified clinician.
The DEKA Administration Set is indicated for gravity administration of general maintenance fluids and supported antibiotics approved for peripheral intravenous (IV) infusion to adult patients under the supervision of a qualified clinician. The DEKA Administration Set is indicated for single patient use only. The DEKA Administration Set is not indicated for administration of high-alert medications, blood, and blood products.
The DEKA Administration Set is compatible with the DEKA Infusion Controller or can be used as a stand-alone administration set for performing manual gravity infusions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232316: DEKA Infusion System, DEKA Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232316
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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