510(k) · Cleared
ClearedSPROTTE NRFit, Quincke NRFit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
PAJUNK GmbH Medizintechnologie · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Oct 27, 2016 as substantially equivalent to K911202 (Pajunk GmbH, 1992) and 1 other predicate after a 267-day review. Its family tree reaches back 3 generations to 1993. 2 of the 10 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Oct 27, 2016
- Review
- 267 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K932249 (1993). 8 ancestors in all, the oldest K911260 (1991). 1 later device descends from it, 1 citing it directly. 2 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK932249 Durasafe B-D Combined Spinal Epidural AnesthesiaBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 2 generations backK954953 B-D Durasafe Combined Spinal Epidural (Cse) TrayBd Becton Dickinson Vacutainer Systems Preanalytic · 1996
- 1 generation backK040965 Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford…Pajunk GmbH · 2004
- This deviceK160295 SPROTTE NRFit, Quincke NRFitPAJUNK GmbH Medizintechnologie · 2016
- Descendant · cites it directly · 0 of its ownK241953 SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH Medizintechnologie · 2024
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH Medizintechnologie · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932249 | Durasafe B-D Combined Spinal Epidural Anesthesia | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −2 | K954953 | B-D Durasafe Combined Spinal Epidural (Cse) Tray | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1996 | — |
| −1 | K040965 | Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles | Pajunk GmbH | 2004 | — |
| 0 (this device) | K160295 | SPROTTE NRFit, Quincke NRFit | PAJUNK GmbH Medizintechnologie | 2016 | — |
| +1 | K241953 | SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology | PAJUNK GmbH Medizintechnologie | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K911202 | Atraumatic Standard Sprotte NeedleSummary page 5…egulatory Class: II Panel: Anesthesiology Predicate Devices: K911202 ATRAUMATIC STANDARD SPROTTE… | 1992 |
| * | K040965 | Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford NeedlesSummary page 5…® (Owner: PAJUNK GmbH Medizintechnologie) K040965 ® (Owner: PAJ… | 2004 |
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 |
|---|---|---|---|
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology | 2024 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
- 2 of the 8 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K241953 (PAJUNK GmbH Medizintechnologie, 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K911202.
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. 2016, 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 SPROTTE® NRFit™, Quincke NRFit™ needles are anesthesia conduction needles which are used to administer anesthetic agent to the subarachnoid space.
The device is intended for adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160295: SPROTTE NRFit, Quincke NRFit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160295
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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