510(k) · Cleared
ClearedMonoject Plastic Hub Spinal Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sherwood Medical Co. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Oct 4, 1982 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 13 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.
- Decided
- Oct 4, 1982
- Review
- 34 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- This deviceK822630 Monoject Plastic Hub Spinal NeedleSherwood Medical Co. · 1982
- Descendant · cites it directly · 11 of its ownK021847 Biopsy Sciences, LLC. Maxi-Cell Biopsy NeedlesBiopsy Sciences, LLC · 2002
- Descendant · 2 generations on · 9 of its ownK142688 Echotip Procore HD Ultrasound Biopsy NeedleCook Ireland, Ltd. · 2014
- Descendant · 3 generations on · 7 of its ownK160229 Echotip Ultra Endobronchial High Definition Ultrasound Needle…Cook Ireland, Ltd. · 2016
- Descendant · 3 generations on · 2 of its ownK210476 EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD…Cook Ireland, Ltd. · 2021 · Recalled
- Descendant · 4 generations on · 2 of its ownK193517 ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · Recalled (Class I)
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193517 ViziShot 2 FLEX4 generations on · 2020
Most influential descendants
Showing 5 of 12 · See all- K021847Biopsy Sciences, LLC. Maxi-Cell Biopsy NeedlesBiopsy Sciences, LLC · 2002 · cites it directly11descendants
- K142688Echotip Procore HD Ultrasound Biopsy NeedleCook Ireland, Ltd. · 2014 · 2 generations on9descendants
- K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd. · 2016 · 3 generations on7descendants
- K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd. · 2021 · 3 generations on2descendants
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K822630 | Monoject Plastic Hub Spinal Needle | Sherwood Medical Co. | 1982 | — |
| +1 | K021847 | Biopsy Sciences, LLC. Maxi-Cell Biopsy Needles | Biopsy Sciences, LLC | 2002 | — |
| +2 | K142688 | Echotip Procore HD Ultrasound Biopsy Needle | Cook Ireland, Ltd. | 2014 | — |
| +3 | K160229 | Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore… | Cook Ireland, Ltd. | 2016 | — |
| +3 | K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound… | Cook Ireland, Ltd. | 2021 | 1 |
| +4 | K193517 | ViziShot 2 FLEX | Olympus Surgical Technologies America | 2020 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 1 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021847 | Biopsy Sciences, LLC. Maxi-Cell Biopsy Needles | 2002 | 11 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K021847 (Biopsy Sciences, LLC, 2002) has gone furthest, with 11 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) | — |
https://510kreport.com/device/K822630 · printed Nov 6, 2026
Cite this page
510(k) Report. “K822630: Monoject Plastic Hub Spinal Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K822630
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026