510(k) · Cleared
ClearedIntravascular Administration Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acta Medical, LLC · FPA Set, Administration, Intravascular
Cleared on Dec 19, 2012 as substantially equivalent to K111351 (Us Infusion Dba Truecare Biomedix, 2011) after a 183-day review. Its family tree reaches back 3 generations to 1993. 4 later devices descend from it.
- Decided
- Dec 19, 2012
- Review
- 183 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K925465 (1993). 4 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK925465 Teleradiology Device & Component of Pacs ComponentLife Care Imaging · 1993
- 2 generations backK050906 Vitalcare I.V. Administration SetVitalcare Group, Inc. · 2005
- 1 generation backK111351 Truecare Biomedix Intravascular Administration Set, Truecare…Us Infusion Dba Truecare Biomedix · 2011
- This deviceK121803 Intravascular Administration SetActa Medical, LLC · 2012
- Descendant · cites it directly · 0 of its ownK230992 DJF Intravascular Administration SetYangzhou Wei DE LI Trade Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK210381 I.V. Administration SetBq Plus Medical Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK162601 Infusion Set for Single UseShinva Ande Healthcare Apparatus Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK150513 Imed Technology Intravascular Administration Set, Imed Technology…Imed Technology, Inc. · 2015
Most influential descendants
Showing 4 of 4 · See all- K230992DJF Intravascular Administration SetYangzhou Wei DE LI Trade Co., Ltd. · 2023 · cites it directly0descendants
- K210381I.V. Administration SetBq Plus Medical Co., Ltd. · 2021 · cites it directly0descendants
- K162601Infusion Set for Single UseShinva Ande Healthcare Apparatus Co., Ltd. · 2017 · cites it directly0descendants
- K150513Imed Technology Intravascular Administration Set, Imed Technology Extension SetImed Technology, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925465 | Teleradiology Device & Component of Pacs Component | Life Care Imaging | 1993 | — |
| −2 | K050906 | Vitalcare I.V. Administration Set | Vitalcare Group, Inc. | 2005 | — |
| −1 | K111351 | Truecare Biomedix Intravascular Administration Set, Truecare Biomedix… | Us Infusion Dba Truecare Biomedix | 2011 | — |
| 0 (this device) | K121803 | Intravascular Administration Set | Acta Medical, LLC | 2012 | — |
| +1 | K230992 | DJF Intravascular Administration Set | Yangzhou Wei DE LI Trade Co., Ltd. | 2023 | — |
| +1 | K210381 | I.V. Administration Set | Bq Plus Medical Co., Ltd. | 2021 | — |
| +1 | K162601 | Infusion Set for Single Use | Shinva Ande Healthcare Apparatus Co., Ltd. | 2017 | — |
| +1 | K150513 | Imed Technology Intravascular Administration Set, Imed Technology Extension Set | Imed Technology, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 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 |
|---|---|---|---|
| * | K111351 | Truecare Biomedix Intravascular Administration Set, Truecare Biomedix Extension SetSummary page 1…Common Name of Device: Intravascular Administration Set Predicate Device: Truecare Biomedix Intravascular Administration Set (K1 1135 1) Panel: General Hospital and Personal Use Product Code: FPA Device Classification: II… | 2011 |
What descends from it? (4)
4 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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K230992 (Yangzhou Wei DE LI Trade Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K111351.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Acta Medical Intravascular administration set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. Acta Medical infusion tubing may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121803: Intravascular 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/K121803
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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