510(k) · Cleared
ClearedVolumetric Infusion Controller
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DEKA Research & Development · LDR Controller, Infusion, Intravascular, Electronic
Cleared on Oct 3, 2016 as substantially equivalent to K863204 (Deka Research & Development Corp., 1986) after a 278-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it.
- Decided
- Oct 3, 2016
- Review
- 278 days
- Class
- Class II
- Product code
- LDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K863204 (1986). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK863204 Deka JR.Deka Research & Development Corp. · 1986
- This deviceK153760 Volumetric Infusion ControllerDEKA Research & Development · 2016
- Descendant · cites it directly · 1 of its ownK232316 DEKA Infusion System, DEKA Administration SetDeka Research and Development · 2024
- Descendant · 2 generations on · 0 of its ownK242693 DEKA Infusion System, DEKA Administration SetDeka Research and Development Corporation · 2024
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 |
|---|---|---|---|---|---|
| −1 | K863204 | Deka JR. | Deka Research & Development Corp. | 1986 | — |
| 0 (this device) | K153760 | Volumetric Infusion Controller | DEKA Research & Development | 2016 | — |
| +1 | K232316 | DEKA Infusion System, DEKA Administration Set | Deka Research and Development | 2024 | — |
| +2 | K242693 | DEKA Infusion System, DEKA Administration Set | Deka Research and Development Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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
- #2 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 |
|---|---|---|---|
| * | K863204 | Deka JR.Summary page 4…cate Device The Volumetric Infusion Controller is substantially equivalent to the DEKA Jr. Volumetric Infusion Controller, which was previously cleared under application K863204. Device Description The Volumetric Infusion Controller (VIC) is a gravity-based electronic infusion controller relying on head h… | 1986 |
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 |
|---|---|---|---|
| K232316 | DEKA Infusion System, DEKA Administration Set | 2024 | 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?
- Its one ancestor has no recall.
- Of its descendants, K232316 (Deka Research and Development, 2024) has gone furthest, with 1 descendant 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. 2016, 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 Volumetric Infusion Controller is intended for the delivery of general maintenance fluids and non-critical antibiotics to adult patients using gravity infusion in a clinical setting by a trained medical professional. The device is not intended to administer critical fluids, including high-risk medications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153760: Volumetric Infusion Controller.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153760
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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