510(k) · Cleared

Cleared

Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)

K070354510(k) TraditionalCleared Oct 5, 2007241-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

International Medical Development, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

Cleared on Oct 5, 2007 as substantially equivalent to K061394 (Busse Hospital Disposables, Inc., 2006) and 2 other predicates after a 241-day review. Its family tree reaches back 3 generations to 1993. 2 of the 19 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.

Decided: Oct 5, 2007
Review: 241 days
Class: Class II
Product code: BSP
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K932249 (1993). 11 ancestors in all, the oldest K895771 (1990). 7 later devices descend from it, 2 citing it directly. 2 of the 19 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 deviceK070354 Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)International Medical Development, Inc. · 2007
Descendant · cites it directly · 5 of its ownK131006 Anesthesia Conduction NeedlesLccs Products Limited · 2013
Descendant · 2 generations on · 3 of its ownK142553 UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable…Unisis Corp. · 2015
Descendant · 3 generations on · 2 of its ownK171518 Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined…Zhejiang Kindly Medical Devices Co., Ltd. · 2018
Descendant · 4 generations on · 0 of its ownK212982 Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited · 2022
Descendant · 4 generations on · 0 of its ownK211085 BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBecton, Dickinson and Company · 2022

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2012high 2 (2022) · low 0 (2014)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 7 · See all

K131006Anesthesia Conduction NeedlesLccs Products Limited · 2013 · cites it directly5descendants
K142553UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked NeedleUnisis Corp. · 2015 · 2 generations on3descendants
K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia NeedlesZhejiang Kindly Medical Devices Co., Ltd. · 2018 · 3 generations on2descendants
K212982Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited · 2022 · 4 generations on0descendants
K211085BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBecton, Dickinson and Company · 2022 · 4 generations on0descendants

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)	K070354	Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)	International Medical Development, Inc.	2007	—
+1	K131006	Anesthesia Conduction Needles	Lccs Products Limited	2013	—
+2	K142553	UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve…	Unisis Corp.	2015	—
+3	K171518	Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia…	Zhejiang Kindly Medical Devices Co., Ltd.	2018	—
+4	K212982	Medispine - Spinal Needle, Glospine - Spinal Needle	Global Medikit Limited	2022	—
+4	K211085	BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle	Becton, Dickinson and Company	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1991	1	1
1992	2	1
1993	2	0
1995	1	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0
2015	1	0
2018	1	0
2019	1	0
2022	2	0

FIG. 1 — Lineage of K070354, 1993–2022Source: 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? (3)

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
*	K061394	Specialty Needles (Spinal Needle, Pencil Point Spinal Needle, Epidural Needle) Summary page 1 …ation date of summary: January 22, 2007 Predicate Devices: 2.1 Busse Hospital Disposables, Inc. Specialty Needles (Spinal Needle, Pencil Point ...), K061394, 09/06/2006; 2.2 Pajunk GMBH's Tuohy Needles, Quincke Needles,. K040965, 09/07/2004; 2.3 IMD's A…	Busse Hospital Disposables, Inc.	2006	—
*	K040965	Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles Summary page 1 …Disposables, Inc. Specialty Needles (Spinal Needle, Pencil Point ...), K061394, 09/06/2006; 2.2 Pajunk GMBH's Tuohy Needles, Quincke Needles,. K040965, 09/07/2004; 2.3 IMD's Anesthetic Needle (Gentie Marx), K931644, 09/22/1993. Device Description: An…	Pajunk GmbH	2004	—
*	K931644	Gertie Marx Needle Summary page 1 …K061394, 09/06/2006; 2.2 Pajunk GMBH's Tuohy Needles, Quincke Needles,. K040965, 09/07/2004; 2.3 IMD's Anesthetic Needle (Gentie Marx), K931644, 09/22/1993. Device Description: Anesthesia conduction needles consist of a luer hub, a stainless steel cannula with…	Intl. Medical-Dental Products USA, Inc.	1993	—

Also cleared against K061394: 1 other device →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K131006	Anesthesia Conduction Needles	Lccs Products Limited	2013	5
K120475	Anesthesia Conduction Needles	Shanghai Samedical & Plastic Instruments Co., Ltd.	2012	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 14 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
2 of the 11 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K131006 (Lccs Products Limited, 2013) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K061394.

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. 2007, 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?

IMD's specialty / anesthesia needles - Tuohy, Quincke and Pencil Point Needles - 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/K070354 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070354: Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070354

Report an extraction error

Are you the manufacturer?

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