510(k) · Cleared

Cleared

Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles

K040965510(k) TraditionalCleared Sep 7, 2004146-day reviewClass II21 CFR 868.5150

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

Pajunk GmbH · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

Cleared on Sep 7, 2004 as substantially equivalent to K953790 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1995) and 5 other predicates after a 146-day review. Its family tree reaches back 2 generations to 1993. 2 of the 44 devices in its family, counting itself, have a Class I recall. 36 later devices descend from it.

Decided: Sep 7, 2004
Review: 146 days
Class: Class II
Product code: BSP
Recalls: None
Predicates: 6

Its longest line of descent runs back 2 generations to K932249 (1993). 7 ancestors in all, the oldest K911260 (1991). 36 later devices descend from it, 11 citing it directly. 2 of the 44 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK932249 Durasafe B-D Combined Spinal Epidural AnesthesiaBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
1 generation backK954953 B-D Durasafe Combined Spinal Epidural (Cse) TrayBd Becton Dickinson Vacutainer Systems Preanalytic · 1996
This deviceK040965 Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford…Pajunk GmbH · 2004
Descendant · cites it directly · 11 of its ownK113207 Sono Tap, Tuohy SonoPajunk GmbH · 2012
Descendant · cites it directly · 7 of its ownK070354 Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)International Medical Development, Inc. · 2007
Descendant · 2 generations on · 5 of its ownK131006 Anesthesia Conduction NeedlesLccs Products Limited · 2013
Descendant · cites it directly · 3 of its ownK160294 SPROTTE NRFit, Quincke NRFit Lumbar Puncture needlesPAJUNK GmbH Medizintechnologie · 2016
Descendant · cites it directly · 3 of its ownK142553 UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable…Unisis Corp. · 2015

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2005high 4 (2008) · low 0 (2010)2026

Class I recalls in this family

K911202 Atraumatic Standard Sprotte Needledirect predicate · 1992
K911260 Atraumatic Standard Sprotte Needledirect predicate · 1991

Most influential descendants

Showing 5 of 36 · See all

K113207Sono Tap, Tuohy SonoPajunk GmbH · 2012 · cites it directly11descendants
K070354Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)International Medical Development, Inc. · 2007 · cites it directly7descendants
K131006Anesthesia Conduction NeedlesLccs Products Limited · 2013 · 2 generations on5descendants
K160294SPROTTE NRFit, Quincke NRFit Lumbar Puncture needlesPAJUNK GmbH Medizintechnologie · 2016 · cites it directly3descendants
K142553UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked NeedleUnisis Corp. · 2015 · cites it directly3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K932249	Durasafe B-D Combined Spinal Epidural Anesthesia	Bd Becton Dickinson Vacutainer Systems Preanalytic	1993	—
−1	K954953	B-D Durasafe Combined Spinal Epidural (Cse) Tray	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996	—
0 (this device)	K040965	Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles	Pajunk GmbH	2004	—
+1	K113207	Sono Tap, Tuohy Sono	Pajunk GmbH	2012	—
+1	K070354	Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)	International Medical Development, Inc.	2007	—
+2	K131006	Anesthesia Conduction Needles	Lccs Products Limited	2013	—
+1	K160294	SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles	PAJUNK GmbH Medizintechnologie	2016	—
+1	K142553	UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve…	Unisis Corp.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	1
1992	2	1
1993	1	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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

FIG. 1 — Lineage of K040965, 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.

2 devices in this family have 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 BSP device

#1 K241954 SonoBlock; SonoBlock IIscore 11.0 · 1 generation · 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? (6)

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
*	K953790	BD Perisafe Epidural Anesthesia Tray Summary page 2 …9 Revised Pages 54-56, August 2004 Predicate Devices: 1. Becton Dickinson spinal needles: K953790 & K954953. 2. Pajunk's anesthesia conduction needles - Tuohy, Quincke, Chiba, and Crawford - consist of the same plasti…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995	—
*	K954953	B-D Durasafe Combined Spinal Epidural (Cse) Tray Summary page 2 …9 Revised Pages 54-56, August 2004 Predicate Devices: 1. Becton Dickinson spinal needles: K953790 & K954953. 2. Pajunk's anesthesia conduction needles - Tuohy, Quincke, Chiba, and Crawford - consist of the same plastic luer hub…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996	—
*	K911202	Atraumatic Standard Sprotte Needle Summary page 2 …ohy, Quincke, Chiba, and Crawford - consist of the same plastic luer hub and metal cannula materials as Pajunk's Sprotte needles cleared under 510(k) numbers K911202, K911221, K911260, and K923003. The only difference between these needle types is the needle tip, which is either pencil-po…	Pajunk GmbH	1992	Class I
*	K911221	Atraumatic Special Sprotte Needle Summary page 2 …cke, Chiba, and Crawford - consist of the same plastic luer hub and metal cannula materials as Pajunk's Sprotte needles cleared under 510(k) numbers K911202, K911221, K911260, and K923003. The only difference between these needle types is the needle tip, which is either pencil-point-tip…	Pajunk GmbH	1992	—
*	K911260	Atraumatic Standard Sprotte Needle Summary page 2 …a, and Crawford - consist of the same plastic luer hub and metal cannula materials as Pajunk's Sprotte needles cleared under 510(k) numbers K911202, K911221, K911260, and K923003. The only difference between these needle types is the needle tip, which is either pencil-point-tip (Spr…	Pajunk GmbH	1991	Class I
*	K923003	Pajunk Standard Sprotte Needle W/ Introducer Cann. Summary page 2 …rd - consist of the same plastic luer hub and metal cannula materials as Pajunk's Sprotte needles cleared under 510(k) numbers K911202, K911221, K911260, and K923003. The only difference between these needle types is the needle tip, which is either pencil-point-tip (Sprotte), bent a…	Rusch, Inc.	1993	—

What descends from it? (36)

See all 36

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

Number	Device	Applicant	Decided	Descendants
K113207	Sono Tap, Tuohy Sono	Pajunk GmbH	2012	11
K070354	Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)	International Medical Development, Inc.	2007	7
K160294	SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles	PAJUNK GmbH Medizintechnologie	2016	3
K142553	UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle	Unisis Corp.	2015	3
K043500	Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad…	Innospine, Inc.	2005	3
K080140	Laurimed Spinal Injection System	Laurimed, LLC	2008	2
K062900	Pajunks Stimulong Tsui-Method Set	PAJUNK GmbH Medizintechnologie	2007	2
K160295	SPROTTE NRFit, Quincke NRFit	PAJUNK GmbH Medizintechnologie	2016	1
K060563	Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV	Pajunk GmbH	2006	1
K052946	MPS Acacia Nerve Block Needle	Mps Acacia	2005	1

Has anything in its family been recalled? (2 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.

K911202Atraumatic Standard Sprotte NeedlePajunk GmbH · 1992 · Direct predicate · ◆ in the 1992 ancestors bar of FIG. 11 Class I recall
K911260Atraumatic Standard Sprotte NeedlePajunk GmbH · 1991 · Direct predicate · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 8.3 years on median.
2 of the 7 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K113207 (Pajunk GmbH, 2012) has gone furthest, with 11 descendants of its own.

How does its category compare?

All BSP devices

BSP Needle, Conduction, Anesthetic (W/Wo Introducer): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BSP

4in 2025

2007high 8 (2008) · low 0 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BSP

170in 2025

2007high 269 (2020) · low 70 (2024)2026

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

Recalls per year · BSP

1in 2020

2007high 1 (2016) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · BSP

86in 2025

2007high 152 (2016) · low 20 (2012)2025

MAUDE reports naming product code BSP, 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	3	189	0	26
2008	8	127	0	24
2009	5	97	0	30
2010	3	79	0	49
2011	3	114	0	33
2012	3	148	0	20
2013	2	—	0	32
2014	2	—	0	41
2015	2	—	0	38
2016	6	268	1	152
2017	4	186	0	34
2018	8	241	0	69
2019	2	—	1	86
2020	3	269	1	78
2021	3	265	0	52
2022	2	—	0	84
2023	0	—	0	75
2024	3	70	0	66
2025	4	170	0	86
2026	0	—	1 (1)	—

What is it indicated for?

Pajunk's anesthesia conduction needles - Tuohy, Quincke, Chiba, and Crawford - are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040965 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040965: Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040965

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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