510(k) · Cleared
ClearedPerfusor Space Infusion Syringe 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 K022575 (B.Braun Medical, Inc., 2002) and 2 other predicates after a 45-day review. Its family tree reaches back 3 generations to 1990. 4 of the 19 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Oct 26, 2006
- Review
- 45 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K904518 (1990). 14 ancestors in all, the oldest K890120 (1989). 4 later devices descend from it, 4 citing it directly. 4 of the 19 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 backK022575 Perfusor Compact with FM SystemB.Braun Medical, Inc. · 2002
- This deviceK062699 Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK092313 Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. · 2009 · Recalled
- Descendant · cites it directly · 0 of its ownK191910 SpaceStation MRIB. Braun Melsugen AG · 2020 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK172831 Perfusor® Space Syringe Infusion Pump SystemB.Braun Medical, Inc. · 2018 · Recalled
- Descendant · cites it directly · 0 of its ownK111381 Medi-Sis Syringe Infusion SystemAcacia, Inc. · 2012
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K092313Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. · 2009 · cites it directly1descendant
- K191910SpaceStation MRIB. Braun Melsugen AG · 2020 · cites it directly0descendants
- K172831Perfusor® Space Syringe Infusion Pump SystemB.Braun Medical, Inc. · 2018 · cites it directly0descendants
- K111381Medi-Sis Syringe Infusion SystemAcacia, Inc. · 2012 · cites it directly0descendants
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 | K022575 | Perfusor Compact with FM System | B.Braun Medical, Inc. | 2002 | — |
| 0 (this device) | 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 |
| +1 | K191910 | SpaceStation MRI | B. Braun Melsugen AG | 2020 | Class I |
| +1 | K172831 | Perfusor® Space Syringe Infusion Pump System | B.Braun Medical, Inc. | 2018 | 4 |
| +1 | K111381 | Medi-Sis Syringe Infusion System | Acacia, Inc. | 2012 | — |
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 |
| 2002 | 1 | 1 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 1 |
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? (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 |
|---|---|---|---|
| * | K022575 | Perfusor Compact with FM SystemSummary page 1…syringe pump: B. Braun Medical Inc. Perfusor®9 compact with fmr-Systemn, marketed uinder cleared 510(k) K022575 and MEDLEYT System with Medication Management System, marketed by… | 2002 |
| * | K030459 | Medley System with Medication Management System (MMS)Summary page 1…with Medication Management System, marketed by ALARIS Medical Systems Inc. under cleared 510(k) K030459 together with MEDLEYT Syringe Pump Module marketed by ALARIS Medical Systems Inc. under cleared… | 2003 |
| * | K023264 | Medley Syringe Pump Module System, Model 8110Summary page 1…together with MEDLEYT Syringe Pump Module marketed by ALARIS Medical Systems Inc. under cleared 510(k; K023264 Cu… | 2002 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 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.
- K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · Direct predicate · ◆ in the 2002 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
- K191910SpaceStation MRIB. Braun Melsugen AG · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 7 of the 14 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K092313 (B.Braun Medical, Inc., 2009) has gone furthest, with 1 descendant 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 Perfusor ® Space Infusion Syringe Pump System includes an external transportable electronic infusion syringe pump 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, intra-arterial, subcutaneous, epidural, irrigation/ablation…
Read the full statement (129 words)
The Perfusor ® Space Infusion Syringe Pump System includes an external transportable electronic infusion syringe pump 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, intra-arterial, subcutaneous, epidural, irrigation/ablation, and enteral. The system is 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 Perfuisor® Space Infusion Syringe 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/K062699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062699: Perfusor Space Infusion Syringe 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/K062699
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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