510(k) · Cleared
ClearedSppro Esp, Models Esp 603-18-05, Esp 603-18-09
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invamed Technologies, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Apr 22, 2004 as substantially equivalent to K980536 (Manan Medical Products, Inc., 1998) and 2 other predicates after a 211-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Apr 22, 2004
- Review
- 211 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K813179 (1981). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K813179 | Perican, Epidural Cannula | Burron Medical Products, Inc. | 1981 | — |
| −1 | K013610 | Perifix Safety Epidural Needles | B.Braun Medical, Inc. | 2002 | — |
| 0 (this device) | K032981 | Sppro Esp, Models Esp 603-18-05, Esp 603-18-09 | Invamed Technologies, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 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? (3)
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 2…oduct Code BSP F. Class Class II Predicate Devices Manan Epidural Needle from Manan Medical Products, Inc. K980536 Manan Spinal Needles from Manan Medical Products, Inc. K983620 Periflx ® Safety Epidural Needle from B. Braun Medical,… | 1998 |
| * | K983620 | Manan Spinal NeedlesSummary page 2…Class II Predicate Devices Manan Epidural Needle from Manan Medical Products, Inc. K980536 Manan Spinal Needles from Manan Medical Products, Inc. K983620 Periflx ® Safety Epidural Needle from B. Braun Medical, Inc. K013610 Device Description Information Intended Use Th… | 1999 |
| * | K013610 | Perifix Safety Epidural NeedlesSummary page 2…anan Medical Products, Inc. K980536 Manan Spinal Needles from Manan Medical Products, Inc. K983620 Periflx ® Safety Epidural Needle from B. Braun Medical, Inc. K013610 Device Description Information Intended Use The SPpro TM ESP is an anesthesia conduction needle incorporating a needle t… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 20.1 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K980536.
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 SPproTM ESP is an anesthesia conduction needle incorporating a needle tip shielding mechanism to aid in the prevention of needle-stick injuries after use to deliver an anesthetic and/or therapeutic agent to provide regional anesthesia. The needle can be used for a single dose administration or in conjunction with a catheter for continuous regional anesthesia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032981: Sppro Esp, Models Esp 603-18-05, Esp 603-18-09.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032981
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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