510(k) · Cleared
ClearedQuincke Spinal Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epimed International, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Jul 30, 2002 after a 39-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Jul 30, 2002
- Review
- 39 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK022029 Quincke Spinal NeedleEpimed International, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK043500 Functional Anaesthetic Discography (Fad) System, Including Fad…Innospine, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 2 of its ownK061210 Functional Anaesthetic Discography (Fad) Catheter System, Model D01A…Kyphon, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK063071 Discyphor Catheter System, Model D01A; Discyphor Introducer Needle…Kyphon, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK073516 Discyphor Direct Catheter System, Discyphor Direct Needles, Long…Kyphon, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK043467 Flexible Spinal NeedleEpimed International, Inc. · 2005
Most influential descendants
Showing 5 of 5 · See all- K043500Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad…Innospine, Inc. · 2005 · cites it directly3descendants
- K061210Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer…Kyphon, Inc. · 2006 · 2 generations on2descendants
- K063071Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01BKyphon, Inc. · 2007 · 2 generations on1descendant
- K073516Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct…Kyphon, Inc. · 2008 · 2 generations on0descendants
- K043467Flexible Spinal NeedleEpimed International, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022029 | Quincke Spinal Needle | Epimed International, Inc. | 2002 | — |
| +1 | K043500 | Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit… | Innospine, Inc. | 2005 | 1 |
| +2 | K061210 | Functional Anaesthetic Discography (Fad) Catheter System, Model D01A… | Kyphon, Inc. | 2006 | — |
| +2 | K063071 | Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B | Kyphon, Inc. | 2007 | — |
| +2 | K073516 | Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor… | Kyphon, Inc. | 2008 | — |
| +1 | K043467 | Flexible Spinal Needle | Epimed International, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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.
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
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 |
|---|---|---|---|
| * | — | Manan Medical Products Spinal Needle Named without a submission number |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K043500 (Innospine, Inc., 2005) has gone furthest, with 3 descendants of its own.
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.
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?
For the spinal administration of anesthetic agents to provide regional anesthesia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022029 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022029: Quincke 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/K022029
Report an extraction error
Are you the manufacturer?
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