510(k) · Cleared
ClearedUniever Disposable Spinal Anesthesia Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unisis Corp. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Oct 31, 2014 as substantially equivalent to K112515 (B.Braun Medical, Inc., 2011) and 1 other predicate after a 183-day review. Its family tree reaches back 2 generations to 1982. 3 later devices descend from it.
- Decided
- Oct 31, 2014
- Review
- 183 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K820047 (1982). 5 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK820047 Spinocan Spinal NeedleBurron Medical Products, Inc. · 1982 · Recalled
- 1 generation backK112515 Pencan Spinal NeedleB.Braun Medical, Inc. · 2011
- This deviceK141126 Uniever Disposable Spinal Anesthesia NeedleUnisis Corp. · 2014
- 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 |
|---|---|---|---|---|---|
| −2 | K820047 | Spinocan Spinal Needle | Burron Medical Products, Inc. | 1982 | 1 |
| −1 | K112515 | Pencan Spinal Needle | B.Braun Medical, Inc. | 2011 | — |
| 0 (this device) | K141126 | Uniever Disposable Spinal Anesthesia Needle | Unisis Corp. | 2014 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
| 2011 | 1 | 0 |
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? (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 |
|---|---|---|---|
| * | K112515 | Pencan Spinal NeedleSummary page 4…l Anesthesia Needle Classification Name: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) Product Code: BSP Class 2 868.5150 Predicate Device: K112515 B.Braun Pencan Spinal Needles, Spinocan Spinal Needles, Spinal Introducer Ne… | 2011 |
| * | K110194 | Medline Epidural and Spinal NeedlesSummary page 4…K112515 B.Braun Pencan Spinal Needles, Spinocan Spinal Needles, Spinal Introducer Needles K110194 Medline Medline Epidural and Spinal Needles Device Description: The UNIEVER Disposable Spinal Anesthesia Needles are a… | 2011 |
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?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 29.9 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K171518 (Zhejiang Kindly Medical Devices Co., Ltd., 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K112515.
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. 2014, 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?
UNIEVER Disposable Spinal Anesthesia Needle is intended to be used for injection of local anesthetic agent into the subarachnoid cavity for pain management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141126: Uniever Disposable Spinal Anesthesia Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141126
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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