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 Oct 26, 2006 as substantially equivalent to K023189 (B.Braun Medical, Inc., 2003) and 3 other predicates after a 45-day review. Its family tree reaches back 3 generations to 1990. 8 of the 34 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it. It has been recalled 3 times, including a Class I recall.
- Decided
- Oct 26, 2006
- Review
- 45 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 3 (1 Class I)
- Predicates
- 4
Its longest line of descent runs back 3 generations to K904518 (1990). 18 ancestors in all, the oldest K820133 (1982). 15 later devices descend from it, 5 citing it directly. 8 of the 34 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 2 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 1 generation backK023189 Vista Basic with FM SystemB.Braun Medical, Inc. · 2003
- This deviceK062700 Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006
- Descendant · cites it directly · 6 of its ownK140838 IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK083689 Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK170595 IV Administration SetsB.Braun Medical, Inc. · 2017 · Recalled
- Descendant · cites it directly · 2 of its ownK121613 Agilia Infusion SystemFresenius Kabi AG · 2013 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK153731 LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC · 2016
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 15 · See all- K140838IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014 · cites it directly6descendants
- K083689Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · cites it directly4descendants
- K170595IV Administration SetsB.Braun Medical, Inc. · 2017 · 2 generations on3descendants
- K121613Agilia Infusion SystemFresenius Kabi AG · 2013 · cites it directly2descendants
- K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC · 2016 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −2 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −1 | K023189 | Vista Basic with FM System | B.Braun Medical, Inc. | 2003 | — |
| 0 (this device) | K062700 | Infusomat Space Volumetric Infusion Pump System | B.Braun Medical, Inc. | 2006 | — |
| +1 | K140838 | IV Administration Set with Hand Pump | B.Braun Medical, Inc. | 2014 | — |
| +1 | K083689 | Infusomat Space Volumetric Infusion Pump System | B.Braun Medical, Inc. | 2009 | Class I |
| +2 | K170595 | IV Administration Sets | B.Braun Medical, Inc. | 2017 | 19 |
| +1 | K121613 | Agilia Infusion System | Fresenius Kabi AG | 2013 | Class I |
| +2 | K153731 | LifeFlow Rapid Infusion Device (LifeFlow Device) | 410 Medical Innovation, LLC | 2016 | — |
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 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K023189 | Vista Basic with FM SystemSummary page 1…PREDICATE DEVICES: Predicate device for infusion pump: B. Braun Medical Inc. Vista Basic withfin System 5 10(k) K023 189; ALARIS Medical Systems, Alaris MedleyTm Patient Care System 51… | 2003 |
| * | K030459 | Medley System with Medication Management System (MMS)Summary page 1…sic withfin System 5 10(k) K023 189; ALARIS Medical Systems, Alaris MedleyTm Patient Care System 510(k) K030459, ALARIS Medical Systems, Alaris MEDLEYT Pump Module 510(k) K9504 19.… | 2003 |
| * | K950419 | The Imed Orion Infusion Pump and Administration SetsSummary page 1…MedleyTm Patient Care System 510(k) K030459, ALARIS Medical Systems, Alaris MEDLEYT Pump Module 510(k) K9504 19. Predicate device for administration sets: B. Braun Medical Inc… | 1995 |
| * | K972678 | Millennium CRT Infusion Pump and Millennium CRT Infusion Pump Administration SetsSummary page 1…n Medical Inc. Millennium CRT Infusion Pump and Millennium CRT Infusion Pump Administration Sets 510(k) K972678. DESCRIPTION: The Infusomat® Space Volumetric Infusion Pump System includes… | 1997 |
What descends from it? (15)
See all 155 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140838 | IV Administration Set with Hand Pump | 2014 | 6 |
| K083689 | Infusomat Space Volumetric Infusion Pump System Class I | 2009 | 4 |
| K121613 | Agilia Infusion System Class I | 2013 | 2 |
| K142036 | Infusomat Space Volumetric Infusion Pump Administration Sets Class I | 2014 | 1 |
| K191910 | SpaceStation MRI Class I | 2020 | 0 |
Has anything in its family been recalled? (8 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.
- K950419The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · Direct predicate · ◆ in the 1995 ancestors bar of FIG. 14 Class I recalls
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K142036Infusomat Space Volumetric Infusion Pump Administration SetsB.Braun Medical, Inc. · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K191910SpaceStation MRIB. Braun Melsugen AG · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
- K121613Agilia Infusion SystemFresenius Kabi AG · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K083689Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K142596Infusomat Space Volumetric Infusion PumpB.Braun Medical, Inc. · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 9 of the 18 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K140838 (B.Braun Medical, Inc., 2014) has gone furthest, with 6 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 Infusomat® Space Volumetric Infusion Pump System includes an external transportable electronic volumetric infusion pump, dedicated administration sets, and pump accessories. The system is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, irrigation/ablation, and…
Read the full statement (123 words)
The Infusomat® Space Volumetric Infusion Pump System includes an external transportable electronic volumetric infusion pump, dedicated administration sets, and pump accessories. The system is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, irrigation/ablation, and enteral. The system is used for the delivery of medications indicated for infusion therapy including but not limited to colloids and crystalloids, blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Infusomat® Space Volumetric Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments (only road ambulances).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062700: Infusomat Space Volumetric Infusion Pump System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062700
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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