510(k) · Cleared
Recalled · Class II · 2017Tuohy Epidural Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epimed International, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Apr 3, 2003 as substantially equivalent to K980536 (Manan Medical Products, Inc., 1998) after a 41-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it. It has been recalled once.
- Decided
- Apr 3, 2003
- Review
- 41 days
- Class
- Class II
- Product code
- BSP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980536 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK980536 Epidural NeedleManan Medical Products, Inc. · 1998
- This deviceK030562 Tuohy Epidural NeedleEpimed International, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK053318 RX Epidural NeedleEpimed International, Inc. · 2006 · Recalled
- Descendant · cites it directly · 0 of its ownK072005 RK Epidural NeedleEpimed International · 2008 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980536 | Epidural Needle | Manan Medical Products, Inc. | 1998 | — |
| 0 (this device) | K030562 | Tuohy Epidural Needle | Epimed International, Inc. | 2003 | — |
| +1 | K053318 | RX Epidural Needle | Epimed International, Inc. | 2006 | 1 |
| +1 | K072005 | RK Epidural Needle | Epimed International | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 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.
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 |
|---|---|---|---|
| * | K980536 | Epidural NeedleSummary page 1…ural Needle Product Class/Classification: Class I1 868.5 150 Needle, Conduction, Anesthetic Predicate Device(s): Manan Medical Products Epidural Needle (K980536) Description: The Tuohy Epidural Needle consists of a stainless steel cannula with a ground beveled distal tip. A pla… | 1998 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 24, 2017 | Class II | Z-0089-2018 | Employee error | Potential for partially incomplete seal of product, impacting sterility. |
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 Epidural Needle is intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030562: Tuohy 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/K030562
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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