510(k) · Cleared
ClearedBusse Extension Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Busse Hospital Disposables · FPA Set, Administration, Intravascular
Cleared on Feb 19, 2015 as substantially equivalent to K103562 (Centurion Medical Products Corporation, 2011) after a 279-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Feb 19, 2015
- Review
- 279 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K960280 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK960280 Ivac Needle Free Valve Administration SetsY · 1996 · Recalled
- 2 generations backK061285 Smartsite Needle Free Valve Administration SetsCardinal Health, Alaris Products · 2006 · Recalled
- 1 generation backK103562 Centurion Pressure Injectable Extension SetCenturion Medical Products Corporation · 2011 · Recalled
- This deviceK141285 Busse Extension SetBusse Hospital Disposables · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960280 | Ivac Needle Free Valve Administration Sets | Y | 1996 | 7 |
| −2 | K061285 | Smartsite Needle Free Valve Administration Sets | Cardinal Health, Alaris Products | 2006 | 2 |
| −1 | K103562 | Centurion Pressure Injectable Extension Set | Centurion Medical Products Corporation | 2011 | 1 |
| 0 (this device) | K141285 | Busse Extension Set | Busse Hospital Disposables | 2015 | — |
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.
Planning a device in FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K103562 | Centurion Pressure Injectable Extension SetSummary page 5…sion Set Intravascular Administration Set Class Il, 21 CFR 880.5440, Product code FPK and FPA Centurion Pressure Injectable Extension Set, Centurion Medical Products, K103562 Busse Extension Set consists of PVC tubing with or without connectors. The tubing accessories include; 3- way connectors, clamps… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 3 of the 3 ancestors have a recall of any class.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
Busse Extension Sets are intended to be used with a vascular access device for administrative and withdrawals of fluids.
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/K141285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141285: Busse Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141285
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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