510(k) · Cleared
Recalled · Class I · 2012Infusomat Space Volumetric Infusion Pump 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 Jul 1, 2009 as substantially equivalent to K062700 (B.Braun Medical, Inc., 2006) and 2 other predicates after a 201-day review. Its family tree reaches back 4 generations to 1990. 7 of the 26 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 3 times, including a Class I recall.
- Decided
- Jul 1, 2009
- Review
- 201 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 3 (1 Class I)
- Predicates
- 3
Its longest line of descent runs back 4 generations to K904518 (1990). 21 ancestors in all, the oldest K820133 (1982). 4 later devices descend from it, 2 citing it directly. 7 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 3 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 2 generations backK023189 Vista Basic with FM SystemB.Braun Medical, Inc. · 2003
- 1 generation backK062700 Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · Recalled (Class I)
- This deviceK083689 Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK121613 Agilia Infusion SystemFresenius Kabi AG · 2013 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK210075 Vigilant Software Suite – Vigilant Master MedFresenius Kabi AG · 2022
- Descendant · 2 generations on · 0 of its ownK210073 Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat…Fresenius Kabi AG · 2022
- Descendant · cites it directly · 0 of its ownK142596 Infusomat Space Volumetric Infusion PumpB.Braun Medical, Inc. · 2015 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K121613Agilia Infusion SystemFresenius Kabi AG · 2013 · cites it directly2descendants
- K210075Vigilant Software Suite – Vigilant Master MedFresenius Kabi AG · 2022 · 2 generations on0descendants
- K210073Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration…Fresenius Kabi AG · 2022 · 2 generations on0descendants
- K142596Infusomat Space Volumetric Infusion PumpB.Braun Medical, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −3 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −2 | 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 |
| 0 (this device) | K083689 | Infusomat Space Volumetric Infusion Pump System | B.Braun Medical, Inc. | 2009 | — |
| +1 | K121613 | Agilia Infusion System | Fresenius Kabi AG | 2013 | Class I |
| +2 | K210075 | Vigilant Software Suite – Vigilant Master Med | Fresenius Kabi AG | 2022 | — |
| +2 | K210073 | Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines… | Fresenius Kabi AG | 2022 | — |
| +1 | K142596 | Infusomat Space Volumetric Infusion Pump | B.Braun Medical, Inc. | 2015 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 2 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 1 |
| 1997 | 1 | 0 |
| 2001 | 1 | 1 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 1 |
| 2015 | 1 | 1 |
| 2022 | 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.
7 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? (3)
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 |
|---|---|---|---|
| * | K062700 | Infusomat Space Volumetric Infusion Pump SystemSummary page 1…original submission of the Infusomat® Space Volumetric Infusion Pump System marketed under cleared 510(k) K062700. The predicate device for barcode and wireless data transmission functionalities is B. Braun Medi… | 2006 |
| * | K011975 | Horizon Outlook with DosecomSummary page 1…n functionalities is B. Braun Medical Inc. Outlook® Safety Infusion System, marketed under cleared 510(k) K011975. The predicate device for PCA functionality is the MEDLEY TM PCA Module marketed by… | 2001 |
| * | K032233 | Medley Pca Module, Model 8120Summary page 1…functionality is the MEDLEY TM PCA Module marketed by ALARIS Medical Systems Inc. under cleared 510(k) K032233. B. Braun Medical Inc. 510(k) Premarket Notification DESCRIPTION: The Infusomat… | 2003 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 23, 2012 | Class II | Z-0623-2013 | Device Design | Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps. |
| Mar 23, 2012 | Class I | Z-1992-2012 | Device Design | Firm became aware of the potential for breakage of the anti free flow clip catch, located on the inside of the pump door, when the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed. If the… |
| Jul 12, 2011 | Not classified | Z-1015-2012 | Device Design | If the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed, the clip catch on the inside of the pump door may break. If the clip catch is broken and the door opened, free flow protection is… |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Direct predicate · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K950419The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · 2 generations back · ◆ in the 1995 ancestors bar of FIG. 14 Class I recalls
- K142596Infusomat Space Volumetric Infusion PumpB.Braun Medical, Inc. · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
- K121613Agilia Infusion SystemFresenius Kabi AG · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 12 of the 21 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K121613 (Fresenius Kabi AG, 2013) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K062700.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 Infusomat® Space Volumetric Infusion Pump System is an electrical, external, volumetric infusion pump system indicated for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083689 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083689: Infusomat Space Volumetric Infusion Pump System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083689
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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