510(k) · Cleared
ClearedBD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Jul 1, 2022 as substantially equivalent to K171518 (Zhejiang Kindly Medical Devices Co., Ltd., 2018) after a 445-day review. Its family tree reaches back 7 generations to 1993. 2 of the 26 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 1, 2022
- Review
- 445 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K932249 (1993). 25 ancestors in all, the oldest K820047 (1982). No later device cites it as a predicate yet. 2 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK932249 Durasafe B-D Combined Spinal Epidural AnesthesiaBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 6 generations backK954953 B-D Durasafe Combined Spinal Epidural (Cse) TrayBd Becton Dickinson Vacutainer Systems Preanalytic · 1996
- 5 generations backK040965 Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford…Pajunk GmbH · 2004
- 4 generations backK070354 Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)International Medical Development, Inc. · 2007
- 3 generations backK131006 Anesthesia Conduction NeedlesLccs Products Limited · 2013
- 2 generations backK142553 UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable…Unisis Corp. · 2015
- 1 generation backK171518 Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined…Zhejiang Kindly Medical Devices Co., Ltd. · 2018
- This deviceK211085 BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBecton, Dickinson and Company · 2022
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K932249 | Durasafe B-D Combined Spinal Epidural Anesthesia | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −6 | K954953 | B-D Durasafe Combined Spinal Epidural (Cse) Tray | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1996 | — |
| −5 | K040965 | Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles | Pajunk GmbH | 2004 | — |
| −4 | K070354 | Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point) | International Medical Development, Inc. | 2007 | — |
| −3 | K131006 | Anesthesia Conduction Needles | Lccs Products Limited | 2013 | — |
| −2 | K142553 | UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve… | Unisis Corp. | 2015 | — |
| −1 | K171518 | Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia… | Zhejiang Kindly Medical Devices Co., Ltd. | 2018 | — |
| 0 (this device) | K211085 | BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle | Becton, Dickinson and Company | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 1 |
| 1992 | 2 | 1 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | K171518 | Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia NeedlesSummary page 4…Anesthesia Needles, Combined Anesthesia Needles 510(k) Reference: K171518 Common Name: Epidural Anesthesia Needles, Spinal Ane… | 2018 |
| † | K193131 | BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer… | 2020 |
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.
What does this lineage say?
- The line of descent spans 29 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- 5 of the 25 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K171518.
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. 2022, 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?
BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™ Weiss Epidural Needle are indicated for the administration of anesthesia or analgesia into the epidural space, or to introduce a dedicated catheter for continuous administration of anesthesia or analgesia into the epidural space. They can also be used to introduce a spinal needle to perform a combined spinal and epidural procedure.
These devices are intended for adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211085 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211085: BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211085
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