510(k) · Cleared
Recalled · Class II · 2017RX 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 Feb 17, 2006 as substantially equivalent to K030562 (Epimed International, Inc., 2003) after a 79-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it. It has been recalled once.
- Decided
- Feb 17, 2006
- Review
- 79 days
- Class
- Class II
- Product code
- BSP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980536 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK980536 Epidural NeedleManan Medical Products, Inc. · 1998
- 1 generation backK030562 Tuohy Epidural NeedleEpimed International, Inc. · 2003 · Recalled
- This deviceK053318 RX Epidural NeedleEpimed International, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK072005 RK Epidural NeedleEpimed International · 2008 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K072005RK Epidural NeedleEpimed International · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980536 | Epidural Needle | Manan Medical Products, Inc. | 1998 | — |
| −1 | K030562 | Tuohy Epidural Needle | Epimed International, Inc. | 2003 | 1 |
| 0 (this device) | K053318 | RX Epidural Needle | Epimed International, Inc. | 2006 | — |
| +1 | K072005 | RK Epidural Needle | Epimed International | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K030562 | Tuohy Epidural NeedleSummary page 1…pidural Needle Product Class/Classification: Class II 868.5150 Needle, Conduction, Anesthetic Predicate Device(s): Epimed International Epidural Needle (K030562) Description: The RX Epidural Needle consists of a stainless steel cannula with a ground beveled distal tip. A plasti… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072005 | RK Epidural Needle | 2008 | 0 |
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-0087-2018 | 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K072005 (Epimed International, 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K030562.
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 RX 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/K053318 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053318: RX Epidural Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053318
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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