510(k) · Cleared
ClearedPerfusor Compact with FM 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 Aug 21, 2002 as substantially equivalent to K994375 (B.Braun Medical, Inc., 2000) and 1 other predicate after a 19-day review. Its family tree reaches back 2 generations to 1990. 3 of the 10 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Aug 21, 2002
- Review
- 19 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K904518 (1990). 4 ancestors in all. 5 later devices descend from it, 1 citing it directly. 3 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 1 generation backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- This deviceK022575 Perfusor Compact with FM SystemB.Braun Medical, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK062699 Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK092313 Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK191910 SpaceStation MRIB. Braun Melsugen AG · 2020 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK172831 Perfusor® Space Syringe Infusion Pump SystemB.Braun Medical, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK111381 Medi-Sis Syringe Infusion SystemAcacia, Inc. · 2012
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K062699Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. · 2006 · cites it directly4descendants
- K092313Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. · 2009 · 2 generations on1descendant
- K191910SpaceStation MRIB. Braun Melsugen AG · 2020 · 2 generations on0descendants
- K172831Perfusor® Space Syringe Infusion Pump SystemB.Braun Medical, Inc. · 2018 · 2 generations on0descendants
- K111381Medi-Sis Syringe Infusion SystemAcacia, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −1 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| 0 (this device) | K022575 | Perfusor Compact with FM System | B.Braun Medical, Inc. | 2002 | — |
| +1 | K062699 | Perfusor Space Infusion Syringe Pump System | B.Braun Medical, Inc. | 2006 | — |
| +2 | K092313 | Perfusor Space Infusion Syringe Pump System | B.Braun Medical, Inc. | 2009 | 4 |
| +2 | K191910 | SpaceStation MRI | B. Braun Melsugen AG | 2020 | Class I |
| +2 | K172831 | Perfusor® Space Syringe Infusion Pump System | B.Braun Medical, Inc. | 2018 | 4 |
| +2 | K111381 | Medi-Sis Syringe Infusion System | Acacia, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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.
3 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 |
|---|---|---|---|
| * | K994375 | Horizon LightSummary page 1…stantial equivalence’ to are the Horizon Outlookm and the Alaris Medley. Patient Care System. The Horizon OutlookTM is marketed by B. Braun Medical under cleared 5 10(k) K994375. The M e d l e y Patient Care System is marketed by Alaris under cleared 510(k) 950419. This substantial equivalence claim is int… | 2000 |
| * | K950419 | The Imed Orion Infusion Pump and Administration SetsSummary page 1…stem. The Horizon OutlookTM is marketed by B. Braun Medical under cleared 5 10(k) K994375. The M e d l e y Patient Care System is marketed by Alaris under cleared 510(k) 950419. This substantial equivalence claim is intended for Food, Drug and Cosmetic Act purposes only. There are no new issues of safety… | 1995 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062699 | Perfusor Space Infusion Syringe Pump System | 2006 | 4 |
Has anything in its family been recalled? (3 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.
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K950419The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · Direct predicate · ◆ in the 1995 ancestors bar of FIG. 14 Class I recalls
- K191910SpaceStation MRIB. Braun Melsugen AG · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- 3 of the 4 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K062699 (B.Braun Medical, Inc., 2006) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K994375.
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 intended use of the Perfusor@compact withfnz system is to provide accurate and continuous flow of parenteral, including blood, and enteral fluids to the patient. The addition of thefnz system extends the abilities of the Perfusor@compact and creates a versatile system that will enhance the administration and management of infusion therapy. Thefnz systenz may be used in a variety of configurations depending on the level of needs of the healthcare…
Read the full statement (177 words)
The intended use of the Perfusor@compact withfnz system is to provide accurate and
continuous flow of parenteral, including blood, and enteral fluids to the patient.
The addition of thefnz system extends the abilities of the Perfusor@compact and creates a
versatile system that will enhance the administration and management of infusion
therapy. Thefnz systenz may be used in a variety of configurations depending on the level
of needs of the healthcare facility.
The new incorporation of a barcode reader and programmable dosing limits are intended
to aid in medication error reduction by decreasing the steps necessary to program an
infusion and to alert the clinician when dose amounts are not within facility defined
parameters.
The Perfusormompact withfin syste~izis intended for but not limited to use in the hospital
and/or other healthcare facilities. The Operation Manual is intended to reinforce the
teaching given to the user by a trained healthcare professional or an authorized B. Braun
Medical Inc. representative. A trained Biomedical Technician must perform a full set-up
of the pump and system before use in a clinical setting
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022575: Perfusor Compact with FM System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022575
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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