510(k) · Cleared
ClearedBD Perisafe Epidural Anesthesia Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · CAZ Anesthesia Conduction Kit
Cleared on Nov 30, 1995 after a 108-day review. The FDA summary names its predicate without a number. 37 later devices descend from it.
- Decided
- Nov 30, 1995
- Review
- 108 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 0
37 later devices descend from it, 1 citing it directly.
- This deviceK953790 BD Perisafe Epidural Anesthesia TrayBd Becton Dickinson Vacutainer Systems Preanalytic · 1995
- Descendant · cites it directly · 36 of its ownK040965 Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford…Pajunk GmbH · 2004
- Descendant · 2 generations on · 11 of its ownK113207 Sono Tap, Tuohy SonoPajunk GmbH · 2012
- Descendant · 2 generations on · 7 of its ownK070354 Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)International Medical Development, Inc. · 2007
- Descendant · 3 generations on · 5 of its ownK131006 Anesthesia Conduction NeedlesLccs Products Limited · 2013
- Descendant · 2 generations on · 3 of its ownK160294 SPROTTE NRFit, Quincke NRFit Lumbar Puncture needlesPAJUNK GmbH Medizintechnologie · 2016
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K040965Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford NeedlesPajunk GmbH · 2004 · cites it directly36descendants
- K113207Sono Tap, Tuohy SonoPajunk GmbH · 2012 · 2 generations on11descendants
- K070354Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)International Medical Development, Inc. · 2007 · 2 generations on7descendants
- K131006Anesthesia Conduction NeedlesLccs Products Limited · 2013 · 3 generations on5descendants
- K160294SPROTTE NRFit, Quincke NRFit Lumbar Puncture needlesPAJUNK GmbH Medizintechnologie · 2016 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953790 | BD Perisafe Epidural Anesthesia Tray | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995 | — |
| +1 | K040965 | Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles | Pajunk GmbH | 2004 | — |
| +2 | K113207 | Sono Tap, Tuohy Sono | Pajunk GmbH | 2012 | — |
| +2 | K070354 | Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point) | International Medical Development, Inc. | 2007 | — |
| +3 | K131006 | Anesthesia Conduction Needles | Lccs Products Limited | 2013 | — |
| +2 | K160294 | SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles | PAJUNK GmbH Medizintechnologie | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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.
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? (5)
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 |
|---|---|---|---|
| * | — | Kendall SafeTrak Continuous Epidural Anesthesia Tray - Catalog No. 5186 Named without a submission number | |
| * | — | Abbott Continuous Epidural Anesthesia Tray - Catalog No. 11826-08 Named without a submission number | |
| * | — | B. Braun PERIPAC Continuous Epidural Anesthesia Tray - Catalog No. CE18TK-10L Named without a submission number | |
| * | — | BD Perisafe Epidural Anesthesia Kit - Catalog No. 405049 Named without a submission number | |
| * | — | Individual components Named without a submission number |
What descends from it? (37)
See all 371 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040965 | Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles | 2004 | 36 |
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?
- Of its descendants, K040965 (Pajunk GmbH, 2004) has gone furthest, with 36 descendants of its own.
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) | — |
https://510kreport.com/device/K953790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953790: BD Perisafe Epidural Anesthesia Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953790
Report an extraction error
Are you the manufacturer?
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