510(k) · Cleared
ClearedVista Basic with FM System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · FRN Pump, Infusion
Cleared on Mar 20, 2003 as substantially equivalent to K994375 (B.Braun Medical, Inc., 2000) and 1 other predicate after a 177-day review. Its family tree reaches back 2 generations to 1990. 8 of the 21 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it.
- Decided
- Mar 20, 2003
- Review
- 177 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K904518 (1990). 4 ancestors in all. 16 later devices descend from it, 1 citing it directly. 8 of the 21 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 1 generation backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- This deviceK023189 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 · 2 generations on · 4 of its ownK083689 Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · Recalled (Class I)
- Descendant · 3 generations on · 3 of its ownK170595 IV Administration SetsB.Braun Medical, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 2 of its ownK121613 Agilia Infusion SystemFresenius Kabi AG · 2013 · Recalled (Class I)
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 16 · See all- 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
- K083689Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · 2 generations on4descendants
- K170595IV Administration SetsB.Braun Medical, Inc. · 2017 · 3 generations on3descendants
- K121613Agilia Infusion SystemFresenius Kabi AG · 2013 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −1 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| 0 (this device) | 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 | — |
| +2 | K083689 | Infusomat Space Volumetric Infusion Pump System | B.Braun Medical, Inc. | 2009 | Class I |
| +3 | K170595 | IV Administration Sets | B.Braun Medical, Inc. | 2017 | 19 |
| +2 | K121613 | Agilia Infusion System | Fresenius Kabi AG | 2013 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 1 |
| 2009 | 1 | 1 |
| 2013 | 1 | 1 |
| 2014 | 2 | 1 |
| 2015 | 1 | 1 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 3 | 1 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2025 | 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.
8 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? (2)
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 |
|---|---|---|---|
| * | K994375 | Horizon LightSummary page 1…tantial equivalence’ to are the Horizon Outlook.. and the Alaris Medleyl. Patient Care System. The Horizon Outlook’M is marketed by B. Braun Medical under cleared 510(k) K994375. The Medley” Patient Care System is marketed by Alaris under cleared 5 10(k) 950419. This substantial equivalence claim is intend… | 2000 |
| * | K950419 | The Imed Orion Infusion Pump and Administration SetsSummary page 5…te device for thefnr sysienr that B Braun Medical is claiming substantial q~ivz!ericcto is the Alaris Medley" Patient Care System, marketed under cleared 5 10(k) K9504 19. Comparison of the Subiect and Predicate Barcode The operation of the subject and predicate barcode label generators a… | 1995 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062700 | Infusomat Space Volumetric Infusion Pump System Class I | 2006 | 15 |
Has anything in its family been recalled? (8 Class I)
No FDA recall names this device.
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.
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K950419The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · Direct predicate · ◆ in the 1995 ancestors bar of FIG. 14 Class I recalls
- K062700Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- 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
- 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 8; all are on the web page.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- 3 of the 4 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K062700 (B.Braun Medical, Inc., 2006) has gone furthest, with 15 descendants of its own.
- 2 other devices also cite its predicate K994375.
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 intended use of the Vista- basic withfm system is to provide accurate and continuous flow of parenteral, including blood, and enteral fluids to the patient. The addition of thefnz systenz extends the abilities of the Vista- basic and creates a versatile system that will enhance the administration and management of infusion therapy. The fnz systenz may be used in a variety of configurations depending on the level of needs of the healthcare facility.…
Read the full statement (182 words)
The intended use of the Vista- basic withfm system is to provide accurate and continuous flow of parenteral, including blood, and enteral fluids to the patient.
The addition of thefnz systenz extends the abilities of the Vista- basic and creates a versatile system that will enhance the administration and management of infusion therapy. The fnz systenz may be used in a variety of configurations depending on the level of needs of the healthcare facility.
The new incorporation of a barcode reader and programmable dosing limits are intended to aid in medication error reduction by decreasing the steps necessary to program an infusion and to alert the clinician when dose amounts are not within facility defined parameters.
The Vista- basic withfnz system is intended for but not limited to use in the hospital and/or other healthcare facilities. The Operation Manual is intended to reinforce the teaching given to the user by a trained healthcare professional or an authorized B. Braun Medical Inc. representative. A trained Biomedical Technician must perform a full set-up of the pump and system before use in a clinical setting
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023189 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023189: Vista Basic with FM System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023189
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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