510(k) · Cleared
ClearedBD Alaris™ Pump Epidural Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Fusion · PWH Administrations Sets With Neuraxial Connectors
Cleared on Jul 21, 2023 as substantially equivalent to K172592 (Smiths Medical Asd, Inc., 2018) after a 441-day review. Its family tree reaches back 2 generations to 2003. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 21, 2023
- Review
- 441 days
- Class
- Class II
- Product code
- PWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K031361 (2003). 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 · 2 generations backK031361 Cadd High-Volume Administration Sets with FlowstopDeltec, Inc. · 2003 · Recalled (Class I)
- 1 generation backK172592 CADD Yellow High Volume Administration Set with NRFit connectorSmiths Medical Asd, Inc. · 2018
- This deviceK221319 BD Alaris™ Pump Epidural Infusion SetCare Fusion · 2023
Class I recalls in this family
- K031361 Cadd High-Volume Administration Sets with Flowstop2 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K031361 | Cadd High-Volume Administration Sets with Flowstop | Deltec, Inc. | 2003 | Class I |
| −1 | K172592 | CADD Yellow High Volume Administration Set with NRFit connector | Smiths Medical Asd, Inc. | 2018 | — |
| 0 (this device) | K221319 | BD Alaris™ Pump Epidural Infusion Set | Care Fusion | 2023 | — |
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 PWH device
- #1 K211649 PCEA Syringe Setscore 3.3 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K172592 | CADD Yellow High Volume Administration Set with NRFit connectorSummary page 4…Trade Name: CADD® Yellow High Volume Administration Set with NRFit™ Connector 510(k) Number: K172592 510(k) Clearance Date: May 17, 2018 Regulation Name: Intravascular Administration Set… | 2018 |
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.
- K031361Cadd High-Volume Administration Sets with FlowstopDeltec, Inc. · 2003 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 15.0 years on median.
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
How does its category compare?
All PWH devicesPWH Administrations Sets With Neuraxial Connectors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PWH
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PWH
Too few PWH 510(k)s in any year since 2007 to give a median.
Recalls per year · PWH
No recall names PWH since 2007.
Adverse event reports per year · PWH
8in 2025
MAUDE reports naming product code PWH, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 1 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 17 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BD Alaris™ Pump Epidural Infusion Set is indicated for use by trained healthcare professionals within healthcare facilities through the epidural route for adults, pediatrics and neonates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221319: BD Alaris™ Pump Epidural Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221319
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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