510(k) · Cleared
Recalled · Class I · 2025Infusomat Space Volumetric Infusion Pump Administration Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · FPA Set, Administration, Intravascular
Cleared on Aug 25, 2014 as substantially equivalent to K062700 (B.Braun Medical, Inc., 2006) after a 28-day review. Its family tree reaches back 4 generations to 1990. 4 of the 21 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 31 times, including 2 Class I recalls.
- Decided
- Aug 25, 2014
- Review
- 28 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 31 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 4 generations to K904518 (1990). 19 ancestors in all, the oldest K820133 (1982). 1 later device descends from it, 1 citing it directly. 4 of the 21 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 deviceK142036 Infusomat Space Volumetric Infusion Pump Administration SetsB.Braun Medical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK243392 Infusomat® Space Volumetric Infusion Pump Administration SetsB.Braun Medical, Inc. · 2025
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K243392Infusomat® Space Volumetric Infusion Pump Administration SetsB.Braun Medical, Inc. · 2025 · 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) | K142036 | Infusomat Space Volumetric Infusion Pump Administration Sets | B.Braun Medical, Inc. | 2014 | — |
| +1 | K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets | B.Braun Medical, Inc. | 2025 | — |
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 |
|---|---|---|
| 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.
4 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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 |
|---|---|---|---|
| * | K062700 | Infusomat Space Volumetric Infusion Pump SystemSummary page 4…uct code BRZ Classification Panel: General Hospital PREDICATE DEVICES: Infusomat® Space Volumetric Infusion Pump System, K062700 ______________________________________________________________________________ DESCRIPTION: The Infusomat® Space Volumetric Inf… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets | 2025 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2025 | Class II | Z-0640-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Jun 17, 2024 | Class II | Z-2384-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2378-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2403-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2388-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2386-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2383-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2399-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2393-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2401-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2389-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2398-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2379-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2385-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2392-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2381-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2397-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2382-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2387-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2394-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2391-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2380-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2402-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2390-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2400-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2396-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Jun 17, 2024 | Class II | Z-2395-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Nov 1, 2023 | Class I | Z-0355-2024 | Process control | In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in… |
| Jun 25, 2021 | Class II | Z-2137-2021 | Process control | There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump. |
| May 1, 2019 | Class I | Z-2489-2019 | Other | Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site). |
| May 9, 2018 | Class II | Z-2285-2018 | Process control | There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter. |
The 5 latest of 31 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 · Direct predicate · ◆ 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
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- 10 of the 19 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K243392 (B.Braun Medical, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K062700.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The Infusomat® Space Volumetric Pump Administration Sets are 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, intra-arterial, subcutaneous, epidural, irrigation/ablation, and enteral. The sets are used for the delivery of medications indicated for infusion therapy…
Read the full statement (112 words)
The Infusomat® Space Volumetric Pump Administration Sets are 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, intra-arterial, subcutaneous, epidural, irrigation/ablation, and enteral. The sets are used for the delivery of medications indicated for infusion therapy including but not limited to drugs like anesthetics, sedatives, analgesics, catecholamines, anticoagulants etc., blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Infusomat Space Volumetric Pump Administration Sets are intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142036: Infusomat Space Volumetric Infusion Pump Administration Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142036
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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