510(k) · Cleared
ClearedTruecare Biomedix Intravascular Administration Set, Truecare Biomedix Extension Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Us Infusion Dba Truecare Biomedix · FPA Set, Administration, Intravascular
Cleared on Sep 29, 2011 as substantially equivalent to K050906 (Vitalcare Group, Inc., 2005) after a 139-day review. Its family tree reaches back 2 generations to 1993. 7 later devices descend from it.
- Decided
- Sep 29, 2011
- Review
- 139 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925465 (1993). 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK925465 Teleradiology Device & Component of Pacs ComponentLife Care Imaging · 1993
- 1 generation backK050906 Vitalcare I.V. Administration SetVitalcare Group, Inc. · 2005
- This deviceK111351 Truecare Biomedix Intravascular Administration Set, Truecare…Us Infusion Dba Truecare Biomedix · 2011
- Descendant · cites it directly · 4 of its ownK121803 Intravascular Administration SetActa Medical, LLC · 2012
- Descendant · 2 generations on · 0 of its ownK230992 DJF Intravascular Administration SetYangzhou Wei DE LI Trade Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK223645 I.V. Administration Set, I.V. Extension SetBq Plus Medical Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK210381 I.V. Administration SetBq Plus Medical Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK162601 Infusion Set for Single UseShinva Ande Healthcare Apparatus Co., Ltd. · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K121803Intravascular Administration SetActa Medical, LLC · 2012 · cites it directly4descendants
- K230992DJF Intravascular Administration SetYangzhou Wei DE LI Trade Co., Ltd. · 2023 · 2 generations on0descendants
- K223645I.V. Administration Set, I.V. Extension SetBq Plus Medical Co., Ltd. · 2023 · cites it directly0descendants
- K210381I.V. Administration SetBq Plus Medical Co., Ltd. · 2021 · 2 generations on0descendants
- K162601Infusion Set for Single UseShinva Ande Healthcare Apparatus Co., Ltd. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925465 | Teleradiology Device & Component of Pacs Component | Life Care Imaging | 1993 | — |
| −1 | K050906 | Vitalcare I.V. Administration Set | Vitalcare Group, Inc. | 2005 | — |
| 0 (this device) | K111351 | Truecare Biomedix Intravascular Administration Set, Truecare Biomedix… | Us Infusion Dba Truecare Biomedix | 2011 | — |
| +1 | K121803 | Intravascular Administration Set | Acta Medical, LLC | 2012 | — |
| +2 | K230992 | DJF Intravascular Administration Set | Yangzhou Wei DE LI Trade Co., Ltd. | 2023 | — |
| +1 | K223645 | I.V. Administration Set, I.V. Extension Set | Bq Plus Medical Co., Ltd. | 2023 | — |
| +2 | K210381 | I.V. Administration Set | Bq Plus Medical Co., Ltd. | 2021 | — |
| +2 | K162601 | Infusion Set for Single Use | Shinva Ande Healthcare Apparatus Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 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 |
|---|---|---|---|
| * | K050906 | Vitalcare I.V. Administration SetSummary page 2…590-5537 Email: Acompton(qi.tcbiornedix.coni Common Name of Device: Intravascular Administration Set Predicate Device: Vitalcare 3 In I Tubing (K050906) Panel: General Hospital and Personal Use Product Code: FPA Device Classification: 11… | 2005 |
What descends from it? (7)
3 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 18 years and passes through 3 companies; a new generation was cleared every 12.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K121803 (Acta Medical, LLC, 2012) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K050906.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Truecare Biomedix Intravascular administration set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. Truecare Biomedix infusion tubing may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111351: Truecare Biomedix Intravascular Administration Set, Truecare Biomedix Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111351
Report an extraction error
Are you the manufacturer?
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