510(k) · Cleared

Cleared

Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles

K171518510(k) TraditionalCleared Jan 5, 2018226-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

Zhejiang Kindly Medical Devices Co., Ltd. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

Cleared on Jan 5, 2018 as substantially equivalent to K142553 (Unisis Corp., 2015) and 2 other predicates after a 226-day review. Its family tree reaches back 6 generations to 1993. 2 of the 27 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.

Decided: Jan 5, 2018
Review: 226 days
Class: Class II
Product code: BSP
Recalls: None
Predicates: 3

Its longest line of descent runs back 6 generations to K932249 (1993). 24 ancestors in all, the oldest K820047 (1982). 2 later devices descend from it, 2 citing it directly. 2 of the 27 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 6 generations backK932249 Durasafe B-D Combined Spinal Epidural AnesthesiaBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
5 generations backK954953 B-D Durasafe Combined Spinal Epidural (Cse) TrayBd Becton Dickinson Vacutainer Systems Preanalytic · 1996
4 generations backK040965 Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford…Pajunk GmbH · 2004
3 generations backK070354 Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)International Medical Development, Inc. · 2007
2 generations backK131006 Anesthesia Conduction NeedlesLccs Products Limited · 2013
1 generation backK142553 UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable…Unisis Corp. · 2015
This deviceK171518 Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined…Zhejiang Kindly Medical Devices Co., Ltd. · 2018
Descendant · cites it directly · 0 of its ownK212982 Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited · 2022
Descendant · cites it directly · 0 of its ownK211085 BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBecton, Dickinson and Company · 2022

Class I recalls in this family

K911202 Atraumatic Standard Sprotte Needle3 generations back · 1992
K911260 Atraumatic Standard Sprotte Needle3 generations back · 1991

Most influential descendants

Showing 2 of 2 · See all

K212982Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited · 2022 · cites it directly0descendants
K211085BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBecton, Dickinson and Company · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K932249	Durasafe B-D Combined Spinal Epidural Anesthesia	Bd Becton Dickinson Vacutainer Systems Preanalytic	1993	—
−5	K954953	B-D Durasafe Combined Spinal Epidural (Cse) Tray	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996	—
−4	K040965	Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles	Pajunk GmbH	2004	—
−3	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	K142553	UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve…	Unisis Corp.	2015	—
0 (this device)	K171518	Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia…	Zhejiang Kindly Medical Devices Co., Ltd.	2018	—
+1	K212982	Medispine - Spinal Needle, Glospine - Spinal Needle	Global Medikit Limited	2022	—
+1	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
1982	1	0
1990	1	0
1991	1	1
1992	2	1
1993	2	0
1994	1	0
1995	1	0
2000	1	0
2001	1	0
2004	1	0
2006	1	0
2008	1	0
2011	2	0
2012	1	0
2014	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	2	0

FIG. 1 — Lineage of K171518, 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
*	K142553	UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle Summary page 6 …t it is secured to the epidural needle to prevent accidental displacement. 5. Identification of Predicate Devices Predicate Device 1 510(k) Number: K142553 Product Name: Uniever Disposable Epidural Anesthesia Needle Predicate Device 2 510(k) Number: K141126…	Unisis Corp.	2015	—
*	K141126	Uniever Disposable Spinal Anesthesia Needle Summary page 6 …Predicate Device 1 510(k) Number: K142553 Product Name: Uniever Disposable Epidural Anesthesia Needle Predicate Device 2 510(k) Number: K141126 Product Name: UNIEVER Disposable Spinal Anesthesia Needle Predicate Device 3 510(k) Number: K993619…	Unisis Corp.	2014	—
*	K993619	Csecure Combined Spinal/Epidural Anesthesia System with Lock Summary page 6 …Predicate Device 2 510(k) Number: K141126 Product Name: UNIEVER Disposable Spinal Anesthesia Needle Predicate Device 3 510(k) Number: K993619 Product Name: CSEcureTM Combined Spinal/Epidural Anesthesia System with Lock 6. Non-Clinical Test Conclusion…	Sims Portex, Inc.	2000	—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K212982	Medispine - Spinal Needle, Glospine - Spinal Needle	Global Medikit Limited	2022	0
K211085	BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle	Becton, Dickinson and Company	2022	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 · 3 generations back · ◆ in the 1992 ancestors bar of FIG. 11 Class I recall
K911260Atraumatic Standard Sprotte NeedlePajunk GmbH · 1991 · 3 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
5 of the 24 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K212982 (Global Medikit Limited, 2022) has gone furthest, with 0 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. 2018, 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 Epidural Anesthesia Needles are intended to be used for injection into the epidural space/or placing the epidural catheter into the epidural space.

The Spinal Anesthesia Needles are intended to be used for injection of local anesthetic agent into the subarachnoid cavity for pain management.

The Combined Anesthesia Needles are intended for injection of local anesthetics into the spinal and epidural spaces of a patient to provide regional anesthesia. The administration of the spinal anesthesia allows rapid anesthesia onset and the placement of an epidural catheter allows for bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K171518 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171518: Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171518

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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