510(k) · Cleared
ClearedEpidural Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Manan Medical Products, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Jul 31, 1998 after a 170-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jul 31, 1998
- Review
- 170 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK980536 Epidural NeedleManan Medical Products, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK030562 Tuohy Epidural NeedleEpimed International, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 1 of its ownK053318 RX Epidural NeedleEpimed International, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK072005 RK Epidural NeedleEpimed International · 2008 · Recalled
- Descendant · cites it directly · 0 of its ownK032981 Sppro Esp, Models Esp 603-18-05, Esp 603-18-09Invamed Technologies, Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K030562Tuohy Epidural NeedleEpimed International, Inc. · 2003 · cites it directly2descendants
- K053318RX Epidural NeedleEpimed International, Inc. · 2006 · 2 generations on1descendant
- K072005RK Epidural NeedleEpimed International · 2008 · 2 generations on0descendants
- K032981Sppro Esp, Models Esp 603-18-05, Esp 603-18-09Invamed Technologies, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980536 | Epidural Needle | Manan Medical Products, Inc. | 1998 | — |
| +1 | K030562 | Tuohy Epidural Needle | Epimed International, Inc. | 2003 | 1 |
| +2 | K053318 | RX Epidural Needle | Epimed International, Inc. | 2006 | 1 |
| +2 | K072005 | RK Epidural Needle | Epimed International | 2008 | 1 |
| +1 | K032981 | Sppro Esp, Models Esp 603-18-05, Esp 603-18-09 | Invamed Technologies, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K030562 (Epimed International, Inc., 2003) has gone furthest, with 2 descendants of its own.
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?
For the epidural placement, directly or through a catheter, of anesthetic agents to elicit regional anesthesia.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980536 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980536: Epidural Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980536
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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