510(k) · Cleared
Recalled · Class II · 2016RK Epidural Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epimed International · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Feb 7, 2008 as substantially equivalent to K030562 (Epimed International, Inc., 2003) and 1 other predicate after a 199-day review. Its family tree reaches back 3 generations to 1998. It has been recalled once.
- Decided
- Feb 7, 2008
- Review
- 199 days
- Class
- Class II
- Product code
- BSP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K980536 (1998). No later device cites it as a predicate yet.
- Root · 3 generations backK980536 Epidural NeedleManan Medical Products, Inc. · 1998
- 2 generations backK030562 Tuohy Epidural NeedleEpimed International, Inc. · 2003 · Recalled
- 1 generation backK053318 RX Epidural NeedleEpimed International, Inc. · 2006 · Recalled
- This deviceK072005 RK Epidural NeedleEpimed International · 2008
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | 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) Epimed International RX Epidural Needle (K053318) Description: The RK Epidural Needle consists of a stainless steel… | 2003 |
| * | K053318 | RX Epidural NeedleSummary page 1…s II 868.5150 Needle, Conduction, Anesthetic Predicate Device(s): Epimed International Epidural Needle (K030562) Epimed International RX Epidural Needle (K053318) Description: The RK Epidural Needle consists of a stainless steel cannula with a ground beveled distal tip. A plasti… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 22, 2016 | Class II | Z-0086-2017 | Employee error | There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 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. 2008, 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 RK Epidural Needle is indicated for either single injection of drug or placement of an Epimed Spring Guided Catheter or traditional epidural catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072005: RK 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/K072005
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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