510(k) · Cleared
ClearedPakter Curved Needle Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Jun 7, 2018 as substantially equivalent to K911260 (Pajunk GmbH, 1991) after a 251-day review. Its family tree reaches back 1 generation to 1991. 1 of the 3 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jun 7, 2018
- Review
- 251 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911260 (1991). 1 later device descends from it, 1 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK911260 Atraumatic Standard Sprotte NeedlePajunk GmbH · 1991 · Recalled (Class I)
- This deviceK173155 Pakter Curved Needle SetCook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK212328 DiscCath Needle SetDisccath, LLC · 2021
Class I recalls in this family
- K911260 Atraumatic Standard Sprotte Needledirect predicate · 1991
Most influential descendants
Showing 1 of 1 · See all- K212328DiscCath Needle SetDisccath, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911260 | Atraumatic Standard Sprotte Needle | Pajunk GmbH | 1991 | Class I |
| 0 (this device) | K173155 | Pakter Curved Needle Set | Cook Incorporated | 2018 | — |
| +1 | K212328 | DiscCath Needle Set | Disccath, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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.
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? (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 |
|---|---|---|---|
| * | K911260 | Atraumatic Standard Sprotte NeedleSummary page 4…Anesthesiology Predicate Device: The Pakter Curved Needle Set is considered substantially equivalent to the following device: Atraumatic Standard Sprotte® Needle (K911260, Pajunk GMBH) cleared on October 21, 1991. Page 2 of 6 Cook Incorporated… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212328 | DiscCath Needle Set | 2021 | 0 |
Has anything in its family been recalled? (1 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.
- K911260Atraumatic Standard Sprotte NeedlePajunk GmbH · 1991 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
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?
The Pakter Curved Needle Set is intended for discography, diagnostic sampling, aspiration, and injection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173155: Pakter Curved Needle Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173155
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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