510(k) · Cleared
ClearedB Dispensing Line
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aea Srl · LHI Set, I.V. Fluid Transfer
Cleared on Sep 27, 2021 as substantially equivalent to K152441 (Kiro Robotics S.L., 2015) after a 285-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Sep 27, 2021
- Review
- 285 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K903493 (1991). 8 ancestors in all, the oldest K894827 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK903493 Namic Contrast Savings Delivery SystemNorth American Instrument Corp. · 1991
- 5 generations backK961794 Fluid Administration Set - Contrast ManagerMerit Medical Systems, Inc. · 1996
- 4 generations backK022431 Medrad Transfer SetMedrad, Inc. · 2002
- 3 generations backK040456 Fleboset MultipleLaboratorios Grifols, S.A. · 2004
- 2 generations backK050339 Set Gri-Fill 3.0-1 Way, 2 Ways, MultipleLaboratorios Grifols, S.A. · 2005
- 1 generation backK152441 KIRO SetKiro Robotics S.L. · 2015
- This deviceK203674 B Dispensing LineAea Srl · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K903493 | Namic Contrast Savings Delivery System | North American Instrument Corp. | 1991 | — |
| −5 | K961794 | Fluid Administration Set - Contrast Manager | Merit Medical Systems, Inc. | 1996 | — |
| −4 | K022431 | Medrad Transfer Set | Medrad, Inc. | 2002 | — |
| −3 | K040456 | Fleboset Multiple | Laboratorios Grifols, S.A. | 2004 | — |
| −2 | K050339 | Set Gri-Fill 3.0-1 Way, 2 Ways, Multiple | Laboratorios Grifols, S.A. | 2005 | — |
| −1 | K152441 | KIRO Set | Kiro Robotics S.L. | 2015 | — |
| 0 (this device) | K203674 | B Dispensing Line | Aea Srl | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K152441 | KIRO SetSummary page 4…ct Code: LHI – NEP (Secondary product code) Panel Identification: General Hospital III. PREDICATE DEVICE KIRO Set (510k Number: K152441, Regulation number: 880.5440, Product code: LHI) Subject device: B Dispensing Line… | 2015 |
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 30 years and passes through 6 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 2 other devices also cite its predicate K152441.
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. 2021, 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?
B Recon Line is intended for transfer of solvent from IV bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system. B Double Filling Line is intended for the transfer of solvent from a bag and liquid drug from a vial to a bag through the APOTECAbag automated system. B Filling Line is intended for transfer of drug from a vial to a bag through the APOTECAbag automated system. B Recon Line with needle is intended for…
Read the full statement (184 words)
B Recon Line is intended for transfer of solvent from IV bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system.
B Double Filling Line is intended for the transfer of solvent from a bag and liquid drug from a vial to a bag through the APOTECAbag automated system.
B Filling Line is intended for transfer of drug from a vial to a bag through the APOTECAbag automated system.
B Recon Line with needle is intended for transfer of solvent from a bag to a vial with powder drug to be reconstituted, through the APOTECAbag automated system.
B Double Filling Line with vial needle is intended for the transfer of solvent from a bag and liquid drug from a bottle to a bag through the APOTECAbag automated system.
B Filling Line for bag is intended for transfer of drug from a bag to another bag through the APOTECAbag automated system.
B Dispensing Line devices are only to be used with APOTECAbag pharmacy compounding device.
These devices are not to be used for the compounding of chemotherapy and oncology drugs.
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/K203674 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203674: B Dispensing Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203674
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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