510(k) Report

510(k) · Cleared

Cleared

Specialty Needles (Spinal Needle, Pencil Point Spinal Needle, Epidural Needle)

K061394510(k) TraditionalCleared Sep 6, 2006110-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

Busse Hospital Disposables, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

Cleared on Sep 6, 2006 as substantially equivalent to K895771 (Exel Intl., 1990) after a 110-day review. Its family tree reaches back 1 generation to 1990. 9 later devices descend from it.

Decided
Sep 6, 2006
Review
110 days
Class
Class II
Product code
BSP
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K895771 (1990). 9 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2008: 1 descendant cleared2013: 1 descendant cleared2012: 1 descendant cleared2015: 1 descendant cleared2019: 1 descendant cleared2018: 1 descendant cleared2022: 2 descendants clearedK895771 · Exel Spinal Needles · Exel Intl. · 19901990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 2 descendants K895771 · Exel Spinal Needles · Exel Intl. · 19900+5
  1. Root · 1 generation backK895771 Exel Spinal NeedlesExel Intl. · 1990
  2. This deviceK061394 Specialty Needles (Spinal Needle, Pencil Point Spinal Needle…Busse Hospital Disposables, Inc. · 2006
  3. Descendant · cites it directly · 7 of its ownK070354 Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)International Medical Development, Inc. · 2007
  4. Descendant · 2 generations on · 5 of its ownK131006 Anesthesia Conduction NeedlesLccs Products Limited · 2013
  5. Descendant · 3 generations on · 3 of its ownK142553 UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable…Unisis Corp. · 2015
  6. Descendant · 4 generations on · 2 of its ownK171518 Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined…Zhejiang Kindly Medical Devices Co., Ltd. · 2018
  7. Descendant · 5 generations on · 0 of its ownK212982 Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited · 2022

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12012: 12013: 12015: 12018: 12019: 12022: 2
2007high 2 (2022) · low 0 (2009)2026

Most influential descendants

Showing 5 of 9 · See all
  • K070354Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)International Medical Development, Inc. · 2007 · cites it directly7descendants
  • K131006Anesthesia Conduction NeedlesLccs Products Limited · 2013 · 2 generations on5descendants
  • K142553UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked NeedleUnisis Corp. · 2015 · 3 generations on3descendants
  • K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia NeedlesZhejiang Kindly Medical Devices Co., Ltd. · 2018 · 4 generations on2descendants
  • K212982Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited · 2022 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K895771Exel Spinal NeedlesExel Intl.1990—
0 (this device)K061394Specialty Needles (Spinal Needle, Pencil Point Spinal Needle, Epidural Needle)Busse Hospital Disposables, Inc.2006—
+1K070354Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)International Medical Development, Inc.2007—
+2K131006Anesthesia Conduction NeedlesLccs Products Limited2013—
+3K142553UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve…Unisis Corp.2015—
+4K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia…Zhejiang Kindly Medical Devices Co., Ltd.2018—
+5K212982Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
201210
201310
201510
201810
201910
202220
FIG. 1 — Lineage of K061394, 1990–2022Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K895771Exel Spinal Needles
Summary page 1
…lassification: Class 11, 21 CFR 868.5150 Product Code: BSP Predicate Device: Exel Spinal Needle - (K895771) Device Description: Anesthesia conduction needles consist of different…
Exel Intl.1990—

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K070354Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)International Medical Development, Inc.20077
K073222Modification to:Specialty NeedlesBusse Hospital Disposables, Inc.20080

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, K070354 (International Medical Development, Inc., 2007) has gone furthest, with 7 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.

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?

specialty needles - Spinal Needle, Pencil Point Needle, and Epidural Needle - 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.

More from Busse Hospital Disposables, Inc.

31 FDA decisions under this applicant name. See the company

  • K120002I-Style Bone Marrow Aspiration Needle with T-HandleBusse Hospital Disposables, Inc. · 2012
  • K093909Busse Surgical Drapes IVBusse Hospital Disposables, Inc. · 2010
  • K092212Busse Surgical Drapes IiiBusse Hospital Disposables, Inc. · 2009
  • K082297Busse Surgical DrapeBusse Hospital Disposables, Inc. · 2008
  • K073222Modification to:Specialty NeedlesBusse Hospital Disposables, Inc. · 2008

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/K061394 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061394: Specialty Needles (Spinal Needle, Pencil Point Spinal Needle, Epidural Needle).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061394

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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