510(k) · Cleared

Cleared

Atraumatic Special Sprotte Needle

K911221510(k) TraditionalCleared Jul 24, 1992493-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 Jul 24, 1992 after a 493-day review. The FDA summary names no predicate by number. 42 later devices descend from it.

Decided: Jul 24, 1992
Review: 493 days
Class: Class II
Product code: BSP
Recalls: None
Predicates: 0

42 later devices descend from it, 5 citing it directly.

This deviceK911221 Atraumatic Special Sprotte NeedlePajunk GmbH · 1992
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 · cites it directly · 9 of its ownK041843 Pencil Point NeedleEpimed International, Inc. · 2004 · Recalled
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

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

1999high 4 (2008) · low 0 (2000)2026

Most influential descendants

Showing 5 of 42 · 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
K041843Pencil Point NeedleEpimed International, Inc. · 2004 · cites it directly9descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K911221	Atraumatic Special Sprotte Needle	Pajunk GmbH	1992	—
+1	K040965	Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles	Pajunk GmbH	2004	—
+2	K113207	Sono Tap, Tuohy Sono	Pajunk GmbH	2012	—
+1	K041843	Pencil Point Needle	Epimed International, Inc.	2004	1
+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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2004	2	0
2005	3	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	4	0
2017	2	0
2018	4	0
2019	1	0
2020	1	0
2022	2	0
2024	1	0
2025	3	0

FIG. 1 — Lineage of K911221, 1992–2025Source: 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 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

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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (42)

See all 42

5 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
K041843	Pencil Point Needle	Epimed International, Inc.	2004	9
K983858	Spinal Anesthesia Needles and Introducer Needles	Sims Portex, Inc.	1999	2
K060563	Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV	Pajunk GmbH	2006	1
K160296	SPROTTE SPECIAL NRFit	PAJUNK GmbH Medizintechnologie	2016	0

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/K911221 · printed Nov 6, 2026

Cite this page

510(k) Report. “K911221: Atraumatic Special Sprotte Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911221

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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