510(k) · Cleared

Cleared

Portex Tuohy Epidural Needle 17G, Portex Tuohy Epidural Needle 18G

K090261510(k) TraditionalCleared May 1, 200987-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

Smiths Medical Asd, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

Cleared on May 1, 2009 as substantially equivalent to K000495 (Ballard Medical Products, 2000) after an 87-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.

Decided: May 1, 2009
Review: 87 days
Class: Class II
Product code: BSP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K000495 (2000). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK000495 Ballard Medical Products Epidural and Spinal NeedlesBallard Medical Products · 2000
This deviceK090261 Portex Tuohy Epidural Needle 17G, Portex Tuohy Epidural Needle 18GSmiths Medical Asd, Inc. · 2009
Descendant · cites it directly · 0 of its ownK172823 Portex NRFit Epidural NeedlesSmiths Medical Asd, Inc. · 2018

Most influential descendants

Showing 1 of 1 · See all

K172823Portex NRFit Epidural NeedlesSmiths Medical Asd, Inc. · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000495	Ballard Medical Products Epidural and Spinal Needles	Ballard Medical Products	2000	—
0 (this device)	K090261	Portex Tuohy Epidural Needle 17G, Portex Tuohy Epidural Needle 18G	Smiths Medical Asd, Inc.	2009	—
+1	K172823	Portex NRFit Epidural Needles	Smiths Medical Asd, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K090261, 2000–2018Source: 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? (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
*	K000495	Ballard Medical Products Epidural and Spinal Needles Summary page 1 …ommon Name: Epidural Anesthesia Needles Classification Name: Needle, Conduction, Anesthetic (W/Wo Introducer) (21 CFR 868.5150, Product Code BSP) Predicate Device(s): K000495, Ballard Medical Products Epidural and Spinal Needles (Now Kimberly Clark) Device Description: Epidural needles are instruments…	Ballard Medical Products	2000	—

Also cleared against K000495: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K172823	Portex NRFit Epidural Needles	Smiths Medical Asd, Inc.	2018	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?

Its one ancestor has no recall.
Of its descendants, K172823 (Smiths Medical Asd, Inc., 2018) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K000495.

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. 2009, 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?

An Epidural Needle is indicated for the injection of anesthetic agents into the epidural space or to facilitate the placement of an epidural catheter.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090261 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090261: Portex Tuohy Epidural Needle 17G, Portex Tuohy Epidural Needle 18G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090261

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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