510(k) · Cleared
ClearedPhoenix Epidural & Spinal Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Myco Medical Supplies, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Jun 2, 2000 after a 470-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jun 2, 2000
- Review
- 470 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK990519 Phoenix Epidural & Spinal NeedlesMyco Medical Supplies, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK183316 Dr J Spinal and Epidural NeedlesDr. Japan Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK203668 RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI…Myco Medical Supplies, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK150266 Remington Medical Inc. Tuohy Epidural NeedlesRemington Medical, Inc. · 2015
Most influential descendants
Showing 3 of 3 · See all- K183316Dr J Spinal and Epidural NeedlesDr. Japan Co., Ltd. · 2019 · cites it directly1descendant
- K203668RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles…Myco Medical Supplies, Inc. · 2021 · 2 generations on0descendants
- K150266Remington Medical Inc. Tuohy Epidural NeedlesRemington Medical, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990519 | Phoenix Epidural & Spinal Needles | Myco Medical Supplies, Inc. | 2000 | — |
| +1 | K183316 | Dr J Spinal and Epidural Needles | Dr. Japan Co., Ltd. | 2019 | — |
| +2 | K203668 | RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal… | Myco Medical Supplies, Inc. | 2021 | — |
| +1 | K150266 | Remington Medical Inc. Tuohy Epidural Needles | Remington Medical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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? (3)
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, K183316 (Dr. Japan Co., Ltd., 2019) has gone furthest, with 1 descendant 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?
Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide 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/K990519 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990519: Phoenix Epidural & Spinal Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990519
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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