510(k) · Cleared

Cleared

Sono Tap, Tuohy Sono

K113207510(k) TraditionalCleared Feb 29, 2012121-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 Feb 29, 2012 as substantially equivalent to K040965 (Pajunk GmbH, 2004) after a 121-day review. Its family tree reaches back 3 generations to 1993. 2 of the 20 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.

Decided: Feb 29, 2012
Review: 121 days
Class: Class II
Product code: BSP
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K932249 (1993). 8 ancestors in all, the oldest K911260 (1991). 11 later devices descend from it, 7 citing it directly. 2 of the 20 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK932249 Durasafe B-D Combined Spinal Epidural AnesthesiaBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
2 generations backK954953 B-D Durasafe Combined Spinal Epidural (Cse) TrayBd Becton Dickinson Vacutainer Systems Preanalytic · 1996
1 generation backK040965 Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford…Pajunk GmbH · 2004
This deviceK113207 Sono Tap, Tuohy SonoPajunk GmbH · 2012
Descendant · cites it directly · 3 of its ownK142553 UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable…Unisis Corp. · 2015
Descendant · 2 generations on · 2 of its ownK171518 Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined…Zhejiang Kindly Medical Devices Co., Ltd. · 2018
Descendant · cites it directly · 1 of its ownK133632 Perican UltraB.Braun Medical, Inc. · 2014
Descendant · cites it directly · 0 of its ownK243690 SonoMSKPAJUNK GmbH Medizintechnologie · 2025
Descendant · cites it directly · 0 of its ownK243525 SonoTAP and SonoTAP IIPAJUNK GmbH Medizintechnologie · 2025

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2014high 2 (2015) · low 0 (2016)2026

Class I recalls in this family

K911202 Atraumatic Standard Sprotte Needle2 generations back · 1992
K911260 Atraumatic Standard Sprotte Needle2 generations back · 1991

Most influential descendants

Showing 5 of 11 · See all

K142553UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked NeedleUnisis Corp. · 2015 · cites it directly3descendants
K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia NeedlesZhejiang Kindly Medical Devices Co., Ltd. · 2018 · 2 generations on2descendants
K133632Perican UltraB.Braun Medical, Inc. · 2014 · cites it directly1descendant
K243690SonoMSKPAJUNK GmbH Medizintechnologie · 2025 · cites it directly0descendants
K243525SonoTAP and SonoTAP IIPAJUNK GmbH Medizintechnologie · 2025 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K932249	Durasafe B-D Combined Spinal Epidural Anesthesia	Bd Becton Dickinson Vacutainer Systems Preanalytic	1993	—
−2	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	—
0 (this device)	K113207	Sono Tap, Tuohy Sono	Pajunk GmbH	2012	—
+1	K142553	UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve…	Unisis Corp.	2015	—
+2	K171518	Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia…	Zhejiang Kindly Medical Devices Co., Ltd.	2018	—
+1	K133632	Perican Ultra	B.Braun Medical, Inc.	2014	—
+1	K243690	SonoMSK	PAJUNK GmbH Medizintechnologie	2025	—
+1	K243525	SonoTAP and SonoTAP II	PAJUNK GmbH Medizintechnologie	2025	—

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
2014	1	0
2015	2	0
2017	2	0
2018	2	0
2022	2	0
2025	2	0

FIG. 1 — Lineage of K113207, 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

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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
*	K040965	Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles Summary page 1 …9611612 Regulatory Class: 11 Panel: Anesthesiology K040965 PAJUNK TUOHY NEEDLES, QUINCKE Predicate Device: NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES…	Pajunk GmbH	2004	—
†	K000722	Unipolar Needles	Pajunk GmbH	2000	—
†	K053283	Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline Set	Pajunk GmbH	2006	—

Also cleared against K040965: 10 other devices →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K142553	UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle	Unisis Corp.	2015	3
K133632	Perican Ultra	B.Braun Medical, Inc.	2014	1
K243690	SonoMSK	PAJUNK GmbH Medizintechnologie	2025	0
K243525	SonoTAP and SonoTAP II	PAJUNK GmbH Medizintechnologie	2025	0
K171968	EchoGlo Needle	Smiths Medical Asd, Inc.	2018	0
K163292	Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford	Spectra Medical Devices	2017	0
K163216	Pinpoint GT Needles	C.R. Bard, Inc.	2017	0

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 · 2 generations back · ◆ in the 1992 ancestors bar of FIG. 11 Class I recall
K911260Atraumatic Standard Sprotte NeedlePajunk GmbH · 1991 · 2 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 7.5 years on median.
2 of the 8 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K142553 (Unisis Corp., 2015) has gone furthest, with 3 descendants of its own.
10 other devices also cite its predicate K040965.

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. 2012, this device’s year, is highlighted.

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?

The cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility - Tuohy Sono, Sono TAP, Quincke Sono, Chiba Sono and Crawford Sono - are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia or to facilitate placement of a catheter.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113207 · printed Nov 3, 2026

Cite this page

510(k) Report. “K113207: Sono Tap, Tuohy Sono.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113207

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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