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 Corporation · LDR Controller, Infusion, Intravascular, Electronic
Cleared on Oct 7, 2024 as substantially equivalent to K232316 (Deka Research and Development, 2024) after a 28-day review. Its family tree reaches back 4 generations to 1983.
- Decided
- Oct 7, 2024
- Review
- 28 days
- Class
- Class II
- Product code
- LDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K832284 (1983). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK832284 Solution Admin. Set 2C9096 W/10 PVCTravenol Laboratories, S.A. · 1983 · Recalled
- 3 generations backK981792 Solution Administration SetBaxter Healthcare Corp · 1998 · Recalled
- 2 generations backK120685 Zyno Medical Administration SetZyno Medical, LLC · 2012
- 1 generation backK232316 DEKA Infusion System, DEKA Administration SetDeka Research and Development · 2024
- This deviceK242693 DEKA Infusion System, DEKA Administration SetDeka Research and Development Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K832284 | Solution Admin. Set 2C9096 W/10 PVC | Travenol Laboratories, S.A. | 1983 | 2 |
| −3 | K981792 | Solution Administration Set | Baxter Healthcare Corp | 1998 | 5 |
| −2 | K120685 | Zyno Medical Administration Set | Zyno Medical, LLC | 2012 | — |
| −1 | K232316 | DEKA Infusion System, DEKA Administration Set | Deka Research and Development | 2024 | — |
| 0 (this device) | 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 |
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 K232316 DEKA Infusion System, DEKA Administration Setscore 10.5 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K232316 | DEKA Infusion System, DEKA Administration SetSummary page 6…of 8 DEKA Research & Development Corp. Predicate Device(s) The subject device is a modified version of the predicate DEKA Infusion System, cleared under K232316 on March 1, 2024. The subject device is substantially equivalent to the predicate DEKA Infusion System. Device Description The… | 2024 |
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 41 years and passes through 5 companies; a new generation was cleared every 14.1 years on median.
- 2 of the 8 ancestors have a recall of any class.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242693 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242693: 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/K242693
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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