510(k) · Cleared

Cleared

Pajunk Standard Sprotte Needle W/ Introducer Cann.

K923003510(k) TraditionalCleared Apr 15, 1993297-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

Rusch, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

Cleared on Apr 15, 1993 after a 297-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 37 later devices descend from it.

Decided: Apr 15, 1993
Review: 297 days
Class: Class II
Product code: BSP
Recalls: None
Predicates: 0

37 later devices descend from it, 1 citing it directly.

This deviceK923003 Pajunk Standard Sprotte Needle W/ Introducer Cann.Rusch, Inc. · 1993
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

2004high 4 (2008) · low 0 (2010)2026

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)	K923003	Pajunk Standard Sprotte Needle W/ Introducer Cann.	Rusch, Inc.	1993	—
+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

FIG. 1 — Lineage of K923003, 1993–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in BSP? 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (37)

See all 37

1 later device cites 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

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 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)	—

https://510kreport.com/device/K923003 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923003: Pajunk Standard Sprotte Needle W/ Introducer Cann..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923003

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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