510(k) · Cleared
Recalled · Class I · 2017The Imed Orion Infusion Pump and Administration Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imed Corp. · FRN Pump, Infusion
Cleared on Jun 21, 1995 after a 141-day review. The FDA summary names its predicate without a number. 10 of the 30 devices in its family, counting itself, have a Class I recall. 29 later devices descend from it. It has been recalled 12 times, including 4 Class I recalls.
- Decided
- Jun 21, 1995
- Review
- 141 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 12 (4 Class I)
- Predicates
- 0
29 later devices descend from it, 5 citing it directly. 10 of the 30 devices in this family, counting this one, have a Class I recall.
- This deviceK950419 The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995
- Descendant · cites it directly · 16 of its ownK023189 Vista Basic with FM SystemB.Braun Medical, Inc. · 2003
- Descendant · cites it directly · 15 of its ownK062700 Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · Recalled (Class I)
- Descendant · 2 generations on · 6 of its ownK140838 IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014
- Descendant · cites it directly · 6 of its ownK051641 Alaris System PC Unit, Model 8001Cardinal Health, Alaris Products · 2005 · Recalled (Class I)
- Descendant · 2 generations on · 5 of its ownK091308 Alaris PC Unit, Models 8000 and 8015Cardinal Health 303,Inc. · 2009
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 29 · See all- K023189Vista Basic with FM SystemB.Braun Medical, Inc. · 2003 · cites it directly16descendants
- K062700Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · cites it directly15descendants
- K140838IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014 · 2 generations on6descendants
- K051641Alaris System PC Unit, Model 8001Cardinal Health, Alaris Products · 2005 · cites it directly6descendants
- K091308Alaris PC Unit, Models 8000 and 8015Cardinal Health 303,Inc. · 2009 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950419 | The Imed Orion Infusion Pump and Administration Sets | Imed Corp. | 1995 | — |
| +1 | K023189 | Vista Basic with FM System | B.Braun Medical, Inc. | 2003 | — |
| +1 | K062700 | Infusomat Space Volumetric Infusion Pump System | B.Braun Medical, Inc. | 2006 | Class I |
| +2 | K140838 | IV Administration Set with Hand Pump | B.Braun Medical, Inc. | 2014 | — |
| +1 | K051641 | Alaris System PC Unit, Model 8001 | Cardinal Health, Alaris Products | 2005 | Class I |
| +2 | K091308 | Alaris PC Unit, Models 8000 and 8015 | Cardinal Health 303,Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 1 |
| 2006 | 2 | 1 |
| 2009 | 3 | 1 |
| 2012 | 2 | 0 |
| 2013 | 1 | 1 |
| 2014 | 3 | 2 |
| 2015 | 1 | 1 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 1 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 1 |
| 2025 | 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.
10 devices in this family have a Class I recall. 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 FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 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 |
|---|---|---|---|
| * | — | IMED Gemini PC-2TX Infusion Pump and Administration Sets Named without a submission number |
What descends from it? (29)
See all 295 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (10 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 9, 2017 | Class II | Z-0026-2018 | Unknown/Undetermined by firm | The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps. |
| Jun 12, 2017 | Class II | Z-2700-2017 | Device Design | There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100. |
| Dec 2, 2016 | Class I | Z-0950-2017 | Component change control | During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted. |
| Apr 23, 2014 | Class I | Z-1567-2014 | Software design | CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose"… |
| Jun 29, 2012 | Class I | Z-2185-2012 | Under Investigation by firm | The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received reports of customers experiencing motor stalls during infusion with Alaris Pump Module… |
| Jun 15, 2012 | Class I | Z-2205-2012 | Device Design | The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly |
| Jun 12, 2009 | Not classified | Z-1794-2009 | Device Design | There is a potential risk of IUI connector failure in the Alaris System when these connectors become corroded or contaminated, which may result in an interruption of infusion with an audible and visual alarm. IUI connectors can become… |
| Jun 12, 2009 | Not classified | Z-1793-2009 | Device Design | There is a potential risk of over infusion when certain fluids solidify in the pumping mechanism of the Alaris Pump module. This notification is to reinforce the importance of proper techniques for IV set loading and cleaning. When IV… |
| Mar 5, 2008 | Not classified | Z-1712-2008 | Device Design | A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failure of the U9 Socketed Integrated Circuits (U9 IC) on the display board of the… |
| Mar 5, 2008 | Not classified | Z-1710-2008 | Device Design | A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failures of the U19 Socketed Integrated Circuits (U19 IC) on the logic board of the… |
| Mar 5, 2008 | Not classified | Z-1711-2008 | Device Design | A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors with the Alaris System due to the Inter-Unit Interface (IUI) connectors on all Alaris System… |
| Nov 10, 2004 | Not classified | Z-0568-05 | Other | The device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module. To date there have… |
The 5 latest of 12 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K062700Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K051641Alaris System PC Unit, Model 8001Cardinal Health, Alaris Products · 2005 · Cites it directly · ◆ in the 2005 descendants bar of FIG. 110 Class I recalls
- K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 128 Class I recalls
- K142036Infusomat Space Volumetric Infusion Pump Administration SetsB.Braun Medical, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K191910SpaceStation MRIB. Braun Melsugen AG · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
- K121613Agilia Infusion SystemFresenius Kabi AG · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K083689Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 17 Class I recalls
- K142596Infusomat Space Volumetric Infusion PumpB.Braun Medical, Inc. · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
Nearest 5 of 9; all are on the web page.
What does this lineage say?
- Of its descendants, K023189 (B.Braun Medical, Inc., 2003) has gone furthest, with 16 descendants of its own.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
The Orion™ Infusion System is intended for use in a health care facility t0 pump standard 1V fluids, medications, whole blood and packed red blood cells into a patientin a controlled manner. The system is electrically powered, with back up battery power available, and uses linear peristaltic pumping action to infuse fluids. The Orion System is capable of detecting air-in-line and occlusions. The Orion System is also indicated for Epidural infusions. Appropriate warnings and precautions 10 safely and accurately infuse Epidural are provided in the product labeling.
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/K950419 · printed Nov 4, 2026
Cite this page
510(k) Report. “K950419: The Imed Orion Infusion Pump and Administration Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950419
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