510(k) · Cleared
ClearedCsecure Combined Spinal/Epidural Anesthesia System with Lock
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sims Portex, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Apr 28, 2000 as substantially equivalent to K932249 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1993) after a 185-day review. Its family tree reaches back 1 generation to 1993. 3 later devices descend from it.
- Decided
- Apr 28, 2000
- Review
- 185 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932249 (1993). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK932249 Durasafe B-D Combined Spinal Epidural AnesthesiaBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- This deviceK993619 Csecure Combined Spinal/Epidural Anesthesia System with LockSims Portex, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK171518 Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined…Zhejiang Kindly Medical Devices Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK212982 Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited · 2022
- Descendant · 2 generations on · 0 of its ownK211085 BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBecton, Dickinson and Company · 2022
Most influential descendants
Showing 3 of 3 · See all- K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia NeedlesZhejiang Kindly Medical Devices Co., Ltd. · 2018 · cites it directly2descendants
- K212982Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited · 2022 · 2 generations on0descendants
- K211085BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBecton, Dickinson and Company · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932249 | Durasafe B-D Combined Spinal Epidural Anesthesia | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| 0 (this device) | K993619 | Csecure Combined Spinal/Epidural Anesthesia System with Lock | Sims Portex, Inc. | 2000 | — |
| +1 | K171518 | Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia… | Zhejiang Kindly Medical Devices Co., Ltd. | 2018 | — |
| +2 | K212982 | Medispine - Spinal Needle, Glospine - Spinal Needle | Global Medikit Limited | 2022 | — |
| +2 | K211085 | BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle | Becton, Dickinson and Company | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 2 | 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.
Planning a device in BSP? 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 |
|---|---|---|---|
| * | K932249 | Durasafe B-D Combined Spinal Epidural AnesthesiaSummary page 1…10 Bowman Drive PO Box 0724 Keene NH 03431 USA Telephone: 603-352-3812 Fax: 603-352-3703 Becton-Dickinson Durasafe™ Combined Spinal/Epidural Anesthesia Needle Set, K932249. DESCRIPTION: Combined Spinal/Epidural Anesthesia Needles are instruments used for a spinal (subarachnoid) injec… | 1993 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171518 | Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles | 2018 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a 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.
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 combined spinal epidural needle kit is intended for injection of local anesthetics
into the intrathecal space via a spinal needle introduced through the epidural needle,
and injection of local anesthetics into the epidural space via the epidural needle, or via
an epidural catheter passed through the epidural needle.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993619 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993619: Csecure Combined Spinal/Epidural Anesthesia System with Lock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993619
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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