510(k) · Decided

Decided

B-D Durasafe Combined Spinal Epidural (Cse) Tray

K954953510(k) TraditionalDecided May 20, 1996203-day reviewClass II21 CFR 868.5140

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bd Becton Dickinson Vacutainer Systems Preanalytic · CAZ Anesthesia Conduction Kit

Cleared on May 20, 1996 as substantially equivalent to K932249 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1993) after a 203-day review. Its family tree reaches back 1 generation to 1993. 39 later devices descend from it.

Decided: May 20, 1996
Review: 203 days
Class: Class II
Product code: CAZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K932249 (1993). 39 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK932249 Durasafe B-D Combined Spinal Epidural AnesthesiaBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
This deviceK954953 B-D Durasafe Combined Spinal Epidural (Cse) TrayBd Becton Dickinson Vacutainer Systems Preanalytic · 1996
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 39 descendants. See all descendants

Descendants cleared per year

2004high 4 (2008) · low 0 (2010)2026

Most influential descendants

Showing 5 of 39 · 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
−1	K932249	Durasafe B-D Combined Spinal Epidural Anesthesia	Bd Becton Dickinson Vacutainer Systems Preanalytic	1993	—
0 (this device)	K954953	B-D Durasafe Combined Spinal Epidural (Cse) Tray	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996	—
+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	3	0
2018	3	0
2019	1	0
2020	2	0
2022	2	0
2024	1	0
2025	3	0

FIG. 1 — Lineage of K954953, 1993–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K932249	Durasafe B-D Combined Spinal Epidural Anesthesia Summary page 1 …ersey 07417-1884 DEVICE NAME BD Stella-Cath™ Combined Spinal/Epidural (CSE) Kit/Tray PREDICATE DEVICE BD Durasafe™ Combined Spinal Epidural Anesthesia Needle Set/Kit (K932249) PRODUCT DESCRIPTION / FUNCTION 4.1 Description - The only change described in this 510(k) is replacing the epidural catheter w…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1993	—

Also cleared against K932249: 2 other devices →

What descends from it? (39)

See all 39

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040965	Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles	Pajunk GmbH	2004	36
K170900	DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6…	Intervene Group, Ltd.	2017	1

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?

Its one ancestor has no recall.
Of its descendants, K040965 (Pajunk GmbH, 2004) has gone furthest, with 36 descendants of its own.
2 other devices also cite its predicate K932249.

How does its category compare?

All CAZ devices

CAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAZ

1in 2023

2007high 9 (2012) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAZ

108in 2012

2007high 172 (2007) · low 99 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CAZ

1in 2024

2007high 29 (2009) · low 0 (2007)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · CAZ

137in 2025

2007high 472 (2019) · low 60 (2023)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?

Regional Anesthesia: To provide a device to accomplish the Combined Spinal (CSE) Epidural Technique

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/K954953 · printed Nov 6, 2026

Cite this page

510(k) Report. “K954953: B-D Durasafe Combined Spinal Epidural (Cse) Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954953

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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