510(k) Report

510(k) · Cleared

Cleared

Flexible Spinal Needle

K043467510(k) TraditionalCleared Mar 31, 2005106-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

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

Cleared on Mar 31, 2005 as substantially equivalent to K022029 (Epimed International, Inc., 2002) and 1 other predicate after a 106-day review. Its family tree reaches back 1 generation to 1993.

Decided
Mar 31, 2005
Review
106 days
Class
Class II
Product code
BSP
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K904380 (1993). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestorK904380 · Spinal Cord Access Epidural Introducer System · Custom Medical Concepts, Inc. · 19931990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K904380 · Spinal Cord Access Epidural Introducer System · Custom Medical Concepts, Inc. · 19930
  1. Root · 1 generation backK904380 Spinal Cord Access Epidural Introducer SystemCustom Medical Concepts, Inc. · 1993
  2. This deviceK043467 Flexible Spinal NeedleEpimed International, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K904380Spinal Cord Access Epidural Introducer SystemCustom Medical Concepts, Inc.1993—
0 (this device)K043467Flexible Spinal NeedleEpimed International, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K043467, 1993–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241954 SonoBlock; SonoBlock IIscore 11.0 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K022029Quincke Spinal Needle
Summary page 2
…anesthesia. Comparison to Predicate: The Flexible Spinal Needle has similar characteristics attributes to both the Epimed Quincke Spinal Needle marketed under K022029 and the Custom Medical Concepts Spinal Cord Access Epidural Introducer System marketed under K904380. Non-Clinical Data:…
Epimed International, Inc.2002—
*K904380Spinal Cord Access Epidural Introducer System
Summary page 2
…utes to both the Epimed Quincke Spinal Needle marketed under K022029 and the Custom Medical Concepts Spinal Cord Access Epidural Introducer System marketed under K904380. Non-Clinical Data: Bench Testing performed on the Flexible Spinal Needle to compare performance characteristics to t…
Custom Medical Concepts, Inc.1993—

Also cleared against K022029: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K022029.

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

2007: 32008: 82009: 52010: 32011: 32012: 32013: 22014: 22015: 22016: 62017: 42018: 82019: 22020: 32021: 32022: 22024: 32025: 4
2007high 8 (2008) · low 0 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BSP

170in 2025

2007: 189 days median2008: 127 days median2009: 97 days median2010: 79 days median2011: 114 days median2012: 148 days median2016: 268 days median2017: 186 days median2018: 241 days median2020: 269 days median2021: 265 days median2024: 70 days median2025: 170 days median
2007high 269 (2020) · low 70 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BSP

1in 2020

2016: 12019: 12020: 12026 (partial year): 1, 1 Class I
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

2007: 262008: 242009: 302010: 492011: 332012: 202013: 322014: 412015: 382016: 1522017: 342018: 692019: 862020: 782021: 522022: 842023: 752024: 662025: 86
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073189026
20088127024
2009597030
2010379049
20113114033
20123148020
20132—032
20142—041
20152—038
201662681152
20174186034
20188241069
20192—186
20203269178
20213265052
20222—084
20230—075
2024370066
20254170086
20260—1 (1)—

What is it indicated for?

The Flexible Spinal Needle is intended for the administration of anesthetic agents to provide regional anesthesia.

Indications for use as stated in the FDA summary.

Also cleared against K022029

1 other device cites the same predicate.

  • K043500Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad Introducer NeedleInnospine, Inc. · 20051 recall

More from Epimed International, Inc.

14 FDA decisions under this applicant name. See the company

  • K200624Percutaneous IntroducerEpimed International, Inc. · 2020
  • K190256Rulo Radiofrequency Lesion ProbeEpimed International, Inc. · 2019
  • K133316Spirol Block (19 GA. Open End Models), (20 GA. Open End Models), (19 GA. Closed End Models), (20 GA. Closed…Epimed International, Inc. · 2014
  • K053318RX Epidural NeedleEpimed International, Inc. · 20061 recall
  • K051171Stingray Epidural Catheter ConnectorEpimed International, Inc. · 20051 recall

Recent decisions in BSP

The BSP category page

  • K243690SonoMSKPAJUNK GmbH Medizintechnologie · 2025
  • K243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH Medizintechnologie · 2025
  • K250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH Medizintechnologie · 2025
  • K243525SonoTAP and SonoTAP IIPAJUNK GmbH Medizintechnologie · 2025
  • K241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH Medizintechnologie · 2024

https://510kreport.com/device/K043467 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043467: Flexible Spinal Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043467

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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