510(k) · Cleared
Recalled · Class I · 2025Becton Dickinson 360 Infuser (TM) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · FRN Pump, Infusion
Cleared on Jul 19, 1990 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 2 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once, including a Class I recall.
- Decided
- Jul 19, 1990
- Review
- 49 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 1 (1 Class I)
- Predicates
- 0
1 later device descends from it, 1 citing it directly. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- This deviceK902409 Becton Dickinson 360 Infuser (TM) SystemBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- Descendant · cites it directly · 0 of its ownK983005 Perfusor CompactB.Braun Medical, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K983005Perfusor CompactB.Braun Medical, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K902409 | Becton Dickinson 360 Infuser (TM) System | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| +1 | K983005 | Perfusor Compact | B.Braun Medical, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K983005 | Perfusor Compact | 1999 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 9, 2025 | Class I | Z-2176-2025 | Process control | Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent, which is common… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K983005 (B.Braun Medical, Inc., 1999) has gone furthest, with 0 descendants 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) | — |
https://510kreport.com/device/K902409 · printed Nov 4, 2026
Cite this page
510(k) Report. “K902409: Becton Dickinson 360 Infuser (TM) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K902409
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026