510(k) · Cleared
ClearedUNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked 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 Jan 14, 2015 as substantially equivalent to K131006 (Lccs Products Limited, 2013) and 4 other predicates after a 126-day review. Its family tree reaches back 5 generations to 1993. 2 of the 20 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Jan 14, 2015
- Review
- 126 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K932249 (1993). 16 ancestors in all, the oldest K895771 (1990). 3 later devices descend from it, 1 citing it directly. 2 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK932249 Durasafe B-D Combined Spinal Epidural AnesthesiaBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 4 generations backK954953 B-D Durasafe Combined Spinal Epidural (Cse) TrayBd Becton Dickinson Vacutainer Systems Preanalytic · 1996
- 3 generations backK040965 Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford…Pajunk GmbH · 2004
- 2 generations backK070354 Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point)International Medical Development, Inc. · 2007
- 1 generation backK131006 Anesthesia Conduction NeedlesLccs Products Limited · 2013
- This deviceK142553 UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable…Unisis Corp. · 2015
- 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
Class I recalls in this family
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 |
|---|---|---|---|---|---|
| −5 | K932249 | Durasafe B-D Combined Spinal Epidural Anesthesia | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −4 | K954953 | B-D Durasafe Combined Spinal Epidural (Cse) Tray | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1996 | — |
| −3 | K040965 | Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles | Pajunk GmbH | 2004 | — |
| −2 | K070354 | Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point) | International Medical Development, Inc. | 2007 | — |
| −1 | K131006 | Anesthesia Conduction Needles | Lccs Products Limited | 2013 | — |
| 0 (this device) | 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 | — |
| +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 |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 1 |
| 1992 | 2 | 1 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 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.
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? (5)
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 |
|---|---|---|---|
| * | K131006 | Anesthesia Conduction NeedlesSummary page 4…erve Block Needle Classification Name: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) Product Code: BSP Class 2 868.5150 Predicate Devices: * K131006 LCCS AN-E Epidural Needle * K040965 Pajunk Tuohy needle, Quincke needle, Chiba needle… | 2013 |
| * | K040965 | Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford NeedlesSummary page 4…IC (W/WO INTRODUCER) Product Code: BSP Class 2 868.5150 Predicate Devices: * K131006 LCCS AN-E Epidural Needle * K040965 Pajunk Tuohy needle, Quincke needle, Chiba needle and * K113207 Crawford needle [… | 2004 |
| * | K113207 | Sono Tap, Tuohy SonoSummary page 4…* K131006 LCCS AN-E Epidural Needle * K040965 Pajunk Tuohy needle, Quincke needle, Chiba needle and * K113207 Crawford needle [Sono] * K041843 Epimed Blunt Nerve Block Needle… | 2012 |
| * | K041843 | Pencil Point NeedleSummary page 4…* K040965 Pajunk Tuohy needle, Quincke needle, Chiba needle and * K113207 Crawford needle [Sono] * K041843 Epimed Blunt Nerve Block Needle * K081864 Life-Tech ProLong Continuous Nerve Block Set Device… | 2004 |
| * | K081864 | ProlongSummary page 4…* K113207 Crawford needle [Sono] * K041843 Epimed Blunt Nerve Block Needle * K081864 Life-Tech ProLong Continuous Nerve Block Set Device Description: The UNIEVER Disposable Epidural Anesthesia Needles and U… | 2008 |
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? (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 22 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 16 ancestors have a recall of any class; 2 have a Class I recall.
- 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 K131006.
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. 2015, 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 Uniever Disposable Epidural Anesthesia Needle is intended to be used for injection into the epidural space / or placing the epidural catheter into the epidural space.
Uniever Disposable Nerve Blockade Needle is intended to be used for injection of local anesthetic agent near the nerve for temporary pain control.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142553 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142553: UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142553
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