510(k) · Cleared
ClearedPerfusor Compact
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 Feb 4, 1999 as substantially equivalent to K844719 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1985) and 1 other predicate after a 160-day review. Its family tree reaches back 1 generation to 1985. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 4, 1999
- Review
- 160 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K844719 (1985). 2 ancestors in all. No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK844719 360 InfuserBd Becton Dickinson Vacutainer Systems Preanalytic · 1985
- This deviceK983005 Perfusor CompactB.Braun Medical, Inc. · 1999
Class I recalls in this family
- K902409 Becton Dickinson 360 Infuser (TM) Systemdirect predicate · 1990
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K844719 | 360 Infuser | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985 | — |
| 0 (this device) | K983005 | Perfusor Compact | B.Braun Medical, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K844719 | 360 InfuserSummary page 2…ice that B. Braun Medical Inc. is claiming substantial equivalencel to is the BD 360 Infuser, (now marketed as 360infuser by B. Braun Medical Inc.) under cleared 510(k)s K844719 and K902409. The 360infuser is an external syringe infusion pump. There are no new issues of safety or effectiveness raised by th… | 1985 |
| * | K902409 | Becton Dickinson 360 Infuser (TM) SystemSummary page 2…Braun Medical Inc. is claiming substantial equivalencel to is the BD 360 Infuser, (now marketed as 360infuser by B. Braun Medical Inc.) under cleared 510(k)s K844719 and K902409. The 360infuser is an external syringe infusion pump. There are no new issues of safety or effectiveness raised by the Perfusor®… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K902409Becton Dickinson 360 Infuser (TM) SystemBd Becton Dickinson Vacutainer Systems Preanalytic · 1990 · Direct predicate · ◆ in the 1990 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class; 1 has 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.
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® compact is a transportable syringe infusion pump that provides infusions of parenteral and enteral fluids. The system created by using syringes validated for use with the Perfusor® compact is intended to provide accurate and continuous flow of parenteral and enteral fluids to the patient. The syringe interacts with the pump so that the size of the syringe is detected. The pump is software controlled and operates using a drive mechanism. The…
Read the full statement (135 words)
The Perfusor® compact is a transportable syringe infusion pump that provides infusions of parenteral and enteral fluids. The system created by using syringes validated for use with the Perfusor® compact is intended to provide accurate and continuous flow of parenteral and enteral fluids to the patient. The syringe interacts with the pump so that the size of the syringe is detected. The pump is software controlled and operates using a drive mechanism.
The Perfusor® compact is intended for but not limited to use in the hospital, home care and/or nursing home (extended care) settings. The Perfusor® compact is intended for use by trained healthcare providers in accordance with the instructions provided in the Operation Manual. All data entry and validation of the Perfusor® compact is performed by the trained healthcare provider per a physician’s order.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983005 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983005: Perfusor Compact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983005
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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