510(k) · Cleared
Recalled · Class II · 2024Perfusor 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. · MEA Pump, Infusion, Pca
Cleared on Nov 4, 2009 as substantially equivalent to K062699 (B.Braun Medical, Inc., 2006) and 2 other predicates after a 97-day review. Its family tree reaches back 4 generations to 1990. 4 of the 19 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Nov 4, 2009
- Review
- 97 days
- Class
- Class II
- Product code
- MEA
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 4 generations to K904518 (1990). 17 ancestors in all, the oldest K890120 (1989). 1 later device descends from it, 1 citing it directly. 4 of the 19 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 backK022575 Perfusor Compact with FM SystemB.Braun Medical, Inc. · 2002
- 1 generation backK062699 Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. · 2006
- This deviceK092313 Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK172831 Perfusor® Space Syringe Infusion Pump SystemB.Braun Medical, Inc. · 2018 · Recalled
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K172831Perfusor® Space Syringe Infusion Pump SystemB.Braun Medical, Inc. · 2018 · 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 | K022575 | Perfusor Compact with FM System | B.Braun Medical, Inc. | 2002 | — |
| −1 | K062699 | Perfusor Space Infusion Syringe Pump System | B.Braun Medical, Inc. | 2006 | — |
| 0 (this device) | K092313 | Perfusor Space Infusion Syringe Pump System | B.Braun Medical, Inc. | 2009 | — |
| +1 | K172831 | Perfusor® Space Syringe Infusion Pump System | B.Braun Medical, Inc. | 2018 | 4 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K062699 | Perfusor Space Infusion Syringe Pump SystemSummary page 1…original submission of the The Perfusor® Space Infusion Syringe Pump System marketed under cleared 510(k) K062699. The predicate device for barcode and out-bound wireless data transmission functionalities is B.… | 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 MEDLEYTM PCA Module… | 2001 |
| * | K032233 | Medley Pca Module, Model 8120Summary page 1…PCA functionality is the MEDLEYTM PCA Module marketed by ALARIS Medical Systems Inc. under cleared 510(k) K032233. B. Braun Medical Inc. 510(k) Premarket Notification DEVICE DESCRIPTION: The Perfusor® Space Infusion Syringe Pu… | 2003 |
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 |
|---|---|---|---|
| K172831 | Perfusor® Space Syringe Infusion Pump System | 2018 | 0 |
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-2436-2024 | 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-2435-2024 | 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-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… |
| 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.
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Direct predicate · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
- 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
- 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 · 3 generations back · ◆ in the 1995 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 9 of the 17 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K172831 (B.Braun Medical, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K062699.
How does its category compare?
All MEA devicesMEA Pump, Infusion, Pca: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MEA
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MEA
Too few MEA 510(k)s in any year since 2007 to give a median.
Recalls per year · MEA
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEA
3,278in 2025
MAUDE reports naming product code MEA, 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 | 0 | — | 0 | 81 |
| 2008 | 1 | — | 1 | 237 |
| 2009 | 1 | — | 0 | 153 |
| 2010 | 0 | — | 4 | 219 |
| 2011 | 0 | — | 2 | 245 |
| 2012 | 0 | — | 0 | 446 |
| 2013 | 1 | — | 0 | 453 |
| 2014 | 0 | — | 1 | 382 |
| 2015 | 0 | — | 0 | 99 |
| 2016 | 1 | — | 0 | 57 |
| 2017 | 2 | — | 2 | 44 |
| 2018 | 0 | — | 0 | 256 |
| 2019 | 0 | — | 0 | 132 |
| 2020 | 0 | — | 0 | 2,331 |
| 2021 | 0 | — | 0 | 3,776 |
| 2022 | 0 | — | 1 | 6,443 |
| 2023 | 0 | — | 0 | 3,984 |
| 2024 | 0 | — | 1 | 4,559 |
| 2025 | 0 | — | 0 | 3,278 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Perfusor® Space Infusion Syringe Pump System is an electrical, external, syringe 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/K092313 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092313: Perfusor Space Infusion Syringe Pump System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092313
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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