510(k) · Cleared
Recalled · Class II · 2017Modification to: BD Durasafe Plus Epidural Lock Cse Needle Set/Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd · CAZ Anesthesia Conduction Kit
Cleared on Sep 6, 2001 as substantially equivalent to K945497 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1995) after a 27-day review. Its family tree reaches back 1 generation to 1995. It has been recalled once.
- Decided
- Sep 6, 2001
- Review
- 27 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945497 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK945497 B-D Durasafe)TM) Variable Extension Combined Spinal Epidural *Cse)…Bd Becton Dickinson Vacutainer Systems Preanalytic · 1995
- This deviceK012584 Modification to: BD Durasafe Plus Epidural Lock Cse Needle Set/KitBd · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945497 | B-D Durasafe)TM) Variable Extension Combined Spinal Epidural *Cse) Needle… | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995 | — |
| 0 (this device) | K012584 | Modification to: BD Durasafe Plus Epidural Lock Cse Needle Set/Kit | Bd | 2001 | — |
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 CAZ? 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 CAZ device
- #1 K261372 Profoject™ LOR Syringescore 12.4 · 2 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 |
|---|---|---|---|
| * | K945497 | B-D Durasafe)TM) Variable Extension Combined Spinal Epidural *Cse) Needle Set/KitSummary page 1…vice Name: BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit 3 Predicate Device(s): 3.1 BD Durasafe™ Variable Extension Combined Spinal Epidural (CSE) Needle Set/Kit K945497. : 4 Intended Uses: The BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit is used to perform the combined spinal/epidural (CSE… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 12, 2017 | Class II | Z-0725-2018 | Process control | The tucking depth feature of this catheter introducer is marginally outside the upper specification. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All CAZ devicesCAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CAZ
108in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAZ
1in 2024
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · CAZ
137in 2025
MAUDE reports naming product code CAZ, 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 | 4 | 172 | 0 | 81 |
| 2008 | 4 | 99 | 0 | 80 |
| 2009 | 2 | — | 29 | 134 |
| 2010 | 2 | — | 8 | 139 |
| 2011 | 1 | — | 2 | 187 |
| 2012 | 9 | 108 | 0 | 187 |
| 2013 | 0 | — | 12 | 276 |
| 2014 | 0 | — | 2 | 251 |
| 2015 | 1 | — | 1 | 235 |
| 2016 | 2 | — | 1 | 372 |
| 2017 | 0 | — | 0 | 353 |
| 2018 | 0 | — | 0 | 448 |
| 2019 | 1 | — | 0 | 472 |
| 2020 | 1 | — | 0 | 274 |
| 2021 | 1 | — | 0 | 165 |
| 2022 | 1 | — | 0 | 270 |
| 2023 | 1 | — | 0 | 60 |
| 2024 | 0 | — | 1 | 165 |
| 2025 | 0 | — | 0 | 137 |
| 2026 | 1 | — | 12 (11) | — |
What is it indicated for?
The BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit is used to
perform the combined spinal/epidural (CSE) anesthesia procedure.
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/K012584 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012584: Modification to: BD Durasafe Plus Epidural Lock Cse Needle Set/Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012584
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026