510(k) · Cleared

Cleared

BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle

K193131510(k) TraditionalCleared Sep 29, 2020322-day reviewClass II21 CFR 868.5150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Becton, Dickinson and Company · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

Cleared on Sep 29, 2020 as substantially equivalent to K160294 (PAJUNK GmbH Medizintechnologie, 2016) after a 322-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: Sep 29, 2020
Review: 322 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.

By dateBy generation

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 deviceK193131 BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD…Becton, Dickinson and Company · 2020

Class I recalls in this family

K911260 Atraumatic Standard Sprotte Needle2 generations back · 1991
K911202 Atraumatic Standard Sprotte Needle3 generations back · 1992

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)	K193131	BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal…	Becton, Dickinson and Company	2020	—

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

FIG. 1 — Lineage of K193131, 1993–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K160294	SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles Summary page 5 …SPROTTE® NRFit™ and Quincke NRFit™ Lumbar Puncture needles 510(k) Reference: K160294 Common Name: Anesthesia Conduction Needle Regulation Number: 21 C…	PAJUNK GmbH Medizintechnologie	2016	—

Also cleared against K160294: 2 other devices →

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.

K911260Atraumatic Standard Sprotte NeedlePajunk GmbH · 1991 · 2 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
K911202Atraumatic Standard Sprotte NeedlePajunk GmbH · 1992 · 3 generations back · ◆ in the 1992 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 27 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 devices

BSP Needle, Conduction, Anesthetic (W/Wo Introducer): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · BSP

4in 2025

2007high 8 (2008) · low 0 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BSP

170in 2025

2007high 269 (2020) · low 70 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BSP

1in 2020

2007high 1 (2016) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · BSP

86in 2025

2007high 152 (2016) · low 20 (2012)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 BD® Spinal Introducer NRFit™ Needle is intended for placement or introduction of spinal needles.

This device is intended for adult and pediatric patients.

The BD® Quincke Spinal NRFit™ Needle and BD® Whitacre Spinal NRFit™ Needle are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture and myelography procedures.

These devices are intended for adult and pediatric patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K193131 · printed Nov 4, 2026

Cite this page

510(k) Report. “K193131: BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193131

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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