510(k) · Cleared
Recalled · Class II · 2024Perfusor® Space Syringe 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 Jun 12, 2018 as substantially equivalent to K092313 (B.Braun Medical, Inc., 2009) and 1 other predicate after a 267-day review. Its family tree reaches back 5 generations to 1990. 4 of the 19 devices in its family, counting itself, have a Class I recall. It has been recalled 4 times.
- Decided
- Jun 12, 2018
- Review
- 267 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 5 generations to K904518 (1990). 18 ancestors in all, the oldest K890120 (1989). No later device cites it as a predicate yet. 4 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 4 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 3 generations backK022575 Perfusor Compact with FM SystemB.Braun Medical, Inc. · 2002
- 2 generations backK062699 Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. · 2006
- 1 generation backK092313 Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. · 2009 · Recalled
- This deviceK172831 Perfusor® Space Syringe Infusion Pump SystemB.Braun Medical, Inc. · 2018
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −4 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −3 | K022575 | Perfusor Compact with FM System | B.Braun Medical, Inc. | 2002 | — |
| −2 | K062699 | Perfusor Space Infusion Syringe Pump System | B.Braun Medical, Inc. | 2006 | — |
| −1 | K092313 | Perfusor Space Infusion Syringe Pump System | B.Braun Medical, Inc. | 2009 | 4 |
| 0 (this device) | K172831 | Perfusor® Space Syringe Infusion Pump System | B.Braun Medical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 1 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 1 |
| 2002 | 1 | 1 |
| 2003 | 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.
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 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 |
|---|---|---|---|
| * | K092313 | Perfusor Space Infusion Syringe Pump SystemSummary page 4…FRN, pump, infusion LZH, pump, infusion, enteral Device Class: Class II Primary Predicate Device: K092313, Perfusor® Space Syringe Infusion Pump System Secondary Predicate Device: K062699, Perfusor® Space Syringe Infusion Pump S… | 2009 |
| * | K062699 | Perfusor Space Infusion Syringe Pump SystemSummary page 4…Device Class: Class II Primary Predicate Device: K092313, Perfusor® Space Syringe Infusion Pump System Secondary Predicate Device: K062699, Perfusor® Space Syringe Infusion Pump System Reference Device K142596, B. Braun Infusomat Space Volumetric I… | 2006 |
| † | K142596 | Infusomat Space Volumetric Infusion Pump | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 14, 2024 | Class II | Z-2433-2024 | Device Design | Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility… |
| Jun 14, 2024 | Class II | Z-2434-2024 | Device Design | Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility… |
| Jun 14, 2024 | Class II | Z-2437-2024 | Device Design | Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility… |
| Feb 7, 2022 | Class II | Z-0819-2022 | Under Investigation by firm | Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion. |
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.
- K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · 2 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 2 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K950419The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · 3 generations back · ◆ in the 1995 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 28 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 10 of the 18 ancestors have a recall of any class; 4 have a Class I recall.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Perfusor® Space Syringe Infusion Pump System is intended for use on adults, pediatrics and neonates for the intermittent or continuous delivery of parenteral fluids, enteral fluids, medications, blood and blood products through clinically accepted routes of administration. These routes include intravenous, intra-arterial, subcutaneous, epidural and enteral.
The Perfusor® Space Syringe Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities and for medical ground and/or air transport situations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172831: Perfusor® Space Syringe 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/K172831
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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