510(k) · Cleared
ClearedPromed Biopsy Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vlv Associates, Inc. · DWO Needle, Biopsy, Cardiovascular
Cleared on Feb 15, 1994 after a 221-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Feb 15, 1994
- Review
- 221 days
- Class
- Class I
- Product code
- DWO
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK933364 Promed Biopsy NeedleVlv Associates, Inc. · 1994
- Descendant · cites it directly · 3 of its ownK140137 Safety Biopsy Needle SystemPfm Medical, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK160423 Perineologic Access NeedleCorbin Clinical Resources, LLC · 2016
- Descendant · 3 generations on · 1 of its ownK210946 Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy…Promisemed Hangzhou Meditech Co., Ltd. · 2021
- Descendant · 4 generations on · 0 of its ownK261196 Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026
Most influential descendants
Showing 4 of 4 · See all- K140137Safety Biopsy Needle SystemPfm Medical, Inc. · 2014 · cites it directly3descendants
- K160423Perineologic Access NeedleCorbin Clinical Resources, LLC · 2016 · 2 generations on2descendants
- K210946Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed…Promisemed Hangzhou Meditech Co., Ltd. · 2021 · 3 generations on1descendant
- K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933364 | Promed Biopsy Needle | Vlv Associates, Inc. | 1994 | — |
| +1 | K140137 | Safety Biopsy Needle System | Pfm Medical, Inc. | 2014 | — |
| +2 | K160423 | Perineologic Access Needle | Corbin Clinical Resources, LLC | 2016 | — |
| +3 | K210946 | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices… | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
| +4 | K261196 | Promisemed VeriEcto Automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 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.
Planning a device in DWO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140137 | Safety Biopsy Needle System | 2014 | 3 |
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, K140137 (Pfm Medical, Inc., 2014) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DWO devicesDWO Needle, Biopsy, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWO
FDA has decided no DWO device since 2007.
Median 510(k) review, days · DWO
Too few DWO 510(k)s in any year since 2007 to give a median.
Recalls per year · DWO
7in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWO
6in 2024
MAUDE reports naming product code DWO, 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 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 7 | 9 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K933364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K933364: Promed Biopsy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933364
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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