510(k) · Cleared
ClearedIMD's Lumbar Puncture Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Medical Development, Inc.(Imd) · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Feb 2, 2018 as substantially equivalent to K160294 (PAJUNK GmbH Medizintechnologie, 2016) after a 386-day review. Its family tree reaches back 4 generations to 1993. 2 of the 10 devices in its family, counting itself, have a Class I recall.
- Decided
- Feb 2, 2018
- Review
- 386 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K932249 (1993). 9 ancestors in all, the oldest K911260 (1991). No later device cites it as a predicate yet. 2 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK932249 Durasafe B-D Combined Spinal Epidural AnesthesiaBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 3 generations backK954953 B-D Durasafe Combined Spinal Epidural (Cse) TrayBd Becton Dickinson Vacutainer Systems Preanalytic · 1996
- 2 generations backK040965 Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford…Pajunk GmbH · 2004
- 1 generation backK160294 SPROTTE NRFit, Quincke NRFit Lumbar Puncture needlesPAJUNK GmbH Medizintechnologie · 2016
- This deviceK170112 IMD's Lumbar Puncture NeedleInternational Medical Development, Inc.(Imd) · 2018
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932249 | Durasafe B-D Combined Spinal Epidural Anesthesia | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −3 | K954953 | B-D Durasafe Combined Spinal Epidural (Cse) Tray | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1996 | — |
| −2 | K040965 | Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles | Pajunk GmbH | 2004 | — |
| −1 | K160294 | SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles | PAJUNK GmbH Medizintechnologie | 2016 | — |
| 0 (this device) | K170112 | IMD's Lumbar Puncture Needle | International Medical Development, Inc.(Imd) | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 1 |
| 1992 | 2 | 1 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K160294 | SPROTTE NRFit, Quincke NRFit Lumbar Puncture needlesSummary page 4…le Product Code: BSP Regulation Nos.: 868.5150 02. PREDICATE AND REFERENCE DEVICES: 2.1 Predicate Device: Pajunct’s Lumber Puncture Needle, K160294, Regulation Number 868.5150, Class II, Product Code BSP, Panel: Anesthesiology, cleared 10/21/2016; Same Inte… | 2016 |
| † | K113662 | Fenestrated Nerve Block Needle | 2012 |
| † | K070354 | Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point) | 2007 |
| † | K931644 | Gertie Marx Needle | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
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.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 8.3 years on median.
- 2 of the 9 ancestors have a recall of any class; 2 have a Class I recall.
- 2 other devices also cite its predicate K160294.
How does its category compare?
All BSP devicesBSP 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
2026 to Oct 25, outlined.
Median 510(k) review, days · BSP
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSP
1in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSP
86in 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 Lumbar Puncture Needle, a single patient use needle; it is intended to gain entry into or puncture the: spinal cavity permitting injecting (including anesthesia) / withdrawl of fluids for purpose of diagnostic lumbar puncture myelography discography procedures.
The device is intended for adult and pediatric patients.
It is to be used only under the direction of a licensed clinician.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170112: IMD's Lumbar Puncture Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170112
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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