510(k) · Cleared
ClearedCADD Yellow High Volume Administration Set with NRFit connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · PWH Administrations Sets With Neuraxial Connectors
Cleared on May 17, 2018 as substantially equivalent to K031361 (Deltec, Inc., 2003) after a 261-day review. Its family tree reaches back 1 generation to 2003. 1 of the 3 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- May 17, 2018
- Review
- 261 days
- Class
- Class II
- Product code
- PWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031361 (2003). 1 later device descends from it, 1 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK031361 Cadd High-Volume Administration Sets with FlowstopDeltec, Inc. · 2003 · Recalled (Class I)
- This deviceK172592 CADD Yellow High Volume Administration Set with NRFit connectorSmiths Medical Asd, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK221319 BD Alaris™ Pump Epidural Infusion SetCare Fusion · 2023
Class I recalls in this family
- K031361 Cadd High-Volume Administration Sets with Flowstopdirect predicate · 2003
Most influential descendants
Showing 1 of 1 · See all- K221319BD Alaris™ Pump Epidural Infusion SetCare Fusion · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031361 | Cadd High-Volume Administration Sets with Flowstop | Deltec, Inc. | 2003 | Class I |
| 0 (this device) | K172592 | CADD Yellow High Volume Administration Set with NRFit connector | Smiths Medical Asd, Inc. | 2018 | — |
| +1 | K221319 | BD Alaris™ Pump Epidural Infusion Set | Care Fusion | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
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 K221319 BD Alaris™ Pump Epidural Infusion Setscore 6.0 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K031361 | Cadd High-Volume Administration Sets with FlowstopSummary page 4…n Set Regulatory Class II II Product Code FPA PWH 510(k) K031361 K172592 4. DEVICE DESCRIPTION The CADD® Yellow High Volume Administration Set with NRFit™ co… | 2003 |
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 |
|---|---|---|---|
| K221319 | BD Alaris™ Pump Epidural Infusion Set | 2023 | 0 |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has a recall, Class I.
- Of its descendants, K221319 (Care Fusion, 2023) has gone furthest, with 0 descendants of its own.
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. 2018, 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?
CADD® Yellow High Volume Administration Sets with NRFit™ connectors are designed for use only with NRFit™ components for delivery of regional anesthetics or narcotics, excluding subarachnoid/spinal block, and are designed for use with CADD® pumps (see CADD® pump Operator’s Manual for compatibility).
The intended population is pediatrics and adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172592: CADD Yellow High Volume Administration Set with NRFit connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172592
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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