510(k) · Cleared
Recalled · Class I · 2026Atraumatic Standard Sprotte Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pajunk GmbH · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on May 4, 1992 after a 412-day review. The FDA summary names no predicate by number. 1 of the 42 devices in its family, counting itself, has a Class I recall. 41 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- May 4, 1992
- Review
- 412 days
- Class
- Class II
- Product code
- BSP
- Recalls
- 1 (1 Class I)
- Predicates
- 0
41 later devices descend from it, 5 citing it directly. 1 of the 42 devices in this family, counting this one, has a Class I recall.
- This deviceK911202 Atraumatic Standard Sprotte NeedlePajunk GmbH · 1992
- Descendant · cites it directly · 36 of its ownK040965 Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford…Pajunk GmbH · 2004
- Descendant · 2 generations on · 11 of its ownK113207 Sono Tap, Tuohy SonoPajunk GmbH · 2012
- Descendant · cites it directly · 9 of its ownK041843 Pencil Point NeedleEpimed International, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 7 of its ownK070354 Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)International Medical Development, Inc. · 2007
- Descendant · 3 generations on · 5 of its ownK131006 Anesthesia Conduction NeedlesLccs Products Limited · 2013
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K040965Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford NeedlesPajunk GmbH · 2004 · cites it directly36descendants
- K113207Sono Tap, Tuohy SonoPajunk GmbH · 2012 · 2 generations on11descendants
- K041843Pencil Point NeedleEpimed International, Inc. · 2004 · cites it directly9descendants
- K070354Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)International Medical Development, Inc. · 2007 · 2 generations on7descendants
- K131006Anesthesia Conduction NeedlesLccs Products Limited · 2013 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911202 | Atraumatic Standard Sprotte Needle | Pajunk GmbH | 1992 | — |
| +1 | K040965 | Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles | Pajunk GmbH | 2004 | — |
| +2 | K113207 | Sono Tap, Tuohy Sono | Pajunk GmbH | 2012 | — |
| +1 | K041843 | Pencil Point Needle | Epimed International, Inc. | 2004 | 1 |
| +2 | K070354 | Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point) | International Medical Development, Inc. | 2007 | — |
| +3 | K131006 | Anesthesia Conduction Needles | Lccs Products Limited | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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.
1 device in this family has 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?
The FDA summary names no predicate by number.
What descends from it? (41)
See all 415 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040965 | Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles | 2004 | 36 |
| K041843 | Pencil Point Needle | 2004 | 9 |
| K983858 | Spinal Anesthesia Needles and Introducer Needles | 1999 | 2 |
| K160295 | SPROTTE NRFit, Quincke NRFit | 2016 | 1 |
| K060563 | Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV | 2006 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2026 | Class I | Z-2389-2026 | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040965 (Pajunk GmbH, 2004) has gone furthest, with 36 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) | — |
https://510kreport.com/device/K911202 · printed Nov 6, 2026
Cite this page
510(k) Report. “K911202: Atraumatic Standard Sprotte Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911202
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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