510(k) · Cleared
ClearedKIRO Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kiro Robotics S.L. · LHI Set, I.V. Fluid Transfer
Cleared on Dec 4, 2015 as substantially equivalent to K050339 (Laboratorios Grifols, S.A., 2005) after a 99-day review. Its family tree reaches back 5 generations to 1991. 3 later devices descend from it.
- Decided
- Dec 4, 2015
- Review
- 99 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K903493 (1991). 7 ancestors in all, the oldest K894827 (1989). 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK903493 Namic Contrast Savings Delivery SystemNorth American Instrument Corp. · 1991
- 4 generations backK961794 Fluid Administration Set - Contrast ManagerMerit Medical Systems, Inc. · 1996
- 3 generations backK022431 Medrad Transfer SetMedrad, Inc. · 2002
- 2 generations backK040456 Fleboset MultipleLaboratorios Grifols, S.A. · 2004
- 1 generation backK050339 Set Gri-Fill 3.0-1 Way, 2 Ways, MultipleLaboratorios Grifols, S.A. · 2005
- This deviceK152441 KIRO SetKiro Robotics S.L. · 2015
- Descendant · cites it directly · 0 of its ownK212530 IVX Fluid Transfer SetOmnicell, Inc. · 2022 · Recalled
- Descendant · cites it directly · 0 of its ownK203674 B Dispensing LineAea Srl · 2021
- Descendant · cites it directly · 0 of its ownK162216 Gri-Fill Peristaltic SetLaboratorios Grifols, S.A. · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903493 | Namic Contrast Savings Delivery System | North American Instrument Corp. | 1991 | — |
| −4 | K961794 | Fluid Administration Set - Contrast Manager | Merit Medical Systems, Inc. | 1996 | — |
| −3 | K022431 | Medrad Transfer Set | Medrad, Inc. | 2002 | — |
| −2 | K040456 | Fleboset Multiple | Laboratorios Grifols, S.A. | 2004 | — |
| −1 | K050339 | Set Gri-Fill 3.0-1 Way, 2 Ways, Multiple | Laboratorios Grifols, S.A. | 2005 | — |
| 0 (this device) | K152441 | KIRO Set | Kiro Robotics S.L. | 2015 | — |
| +1 | K212530 | IVX Fluid Transfer Set | Omnicell, Inc. | 2022 | 1 |
| +1 | K203674 | B Dispensing Line | Aea Srl | 2021 | — |
| +1 | K162216 | Gri-Fill Peristaltic Set | Laboratorios Grifols, S.A. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 LHI? 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 LHI device
- #1 K252987 ADRx™ Admixture Devicescore 12.4 · 4 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 |
|---|---|---|---|
| * | K050339 | Set Gri-Fill 3.0-1 Way, 2 Ways, MultipleSummary page 4…LHI Secondary Product Code: NEP Class: II III. PREDICATE DEVICE Predicate Device Sets Gri-Fill 3.0, K050339 This predicate device has not been subject to a recall. Reference Device Baxa Tubing Set (for Pharmacy… | 2005 |
| † | K872743 | Baxa Tubing Sets (for Pharmacy Pump) | 1987 |
What descends from it? (3)
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 24 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K212530 (Omnicell, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K050339.
How does its category compare?
All LHI devicesLHI Set, I.V. Fluid Transfer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · LHI
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHI
196in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHI
1in 2024
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · LHI
1,334in 2025
MAUDE reports naming product code LHI, 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 | 3 | 89 | 1 | 18 |
| 2008 | 4 | 154 | 3 | 27 |
| 2009 | 8 | 95 | 1 | 37 |
| 2010 | 5 | 139 | 3 | 49 |
| 2011 | 3 | 99 | 12 | 155 |
| 2012 | 5 | 127 | 0 | 529 |
| 2013 | 4 | 102 | 3 | 154 |
| 2014 | 6 | 63 | 0 | 155 |
| 2015 | 3 | 99 | 0 | 128 |
| 2016 | 3 | 159 | 1 (1) | 219 |
| 2017 | 5 | 56 | 1 | 536 |
| 2018 | 1 | — | 3 (3) | 1,499 |
| 2019 | 4 | 247 | 1 | 1,634 |
| 2020 | 3 | 189 | 0 | 1,171 |
| 2021 | 3 | 396 | 0 | 933 |
| 2022 | 6 | 278 | 2 | 1,834 |
| 2023 | 5 | 90 | 2 (2) | 1,047 |
| 2024 | 9 | 166 | 1 | 1,270 |
| 2025 | 6 | 196 | 0 | 1,334 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The KIRO Set is a sterile, single-use disposable ancillary device used with the peristaltic pumps in the KIRO Oncology pharmacy compounding device for the transfer of fluids into sterile powder drug vials for reconstitution of intravenous drugs or into sterile medication containers for intravenous drug administration.
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/K152441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152441: KIRO Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152441
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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