510(k) · Cleared
ClearedNeedle W/Stylet for Implantation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microvasive · GAA Needle, Aspiration And Injection, Disposable
Cleared on Nov 13, 1985 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Nov 13, 1985
- Review
- 23 days
- Class
- Class I
- Product code
- GAA
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK854238 Needle W/Stylet for ImplantationMicrovasive · 1985
- Descendant · cites it directly · 6 of its ownK942301 Microvasive Injection Gold ProbeBoston Scientific Corp · 1994
- Descendant · 2 generations on · 5 of its ownK961349 Injection Gold ProbeBoston Scientific Corp · 1996
- Descendant · 3 generations on · 4 of its ownK110887 Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation · 2011
- Descendant · 4 generations on · 3 of its ownK133933 Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation · 2014
- Descendant · 5 generations on · 1 of its ownK171983 Creo Medical Electrosurgical System including Speedboat RS2 Surgical…Creo Medical, Ltd. · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K942301Microvasive Injection Gold ProbeBoston Scientific Corp · 1994 · cites it directly6descendants
- K961349Injection Gold ProbeBoston Scientific Corp · 1996 · 2 generations on5descendants
- K110887Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation · 2011 · 3 generations on4descendants
- K133933Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation · 2014 · 4 generations on3descendants
- K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryCreo Medical, Ltd. · 2017 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K854238 | Needle W/Stylet for Implantation | Microvasive | 1985 | — |
| +1 | K942301 | Microvasive Injection Gold Probe | Boston Scientific Corp | 1994 | — |
| +2 | K961349 | Injection Gold Probe | Boston Scientific Corp | 1996 | — |
| +3 | K110887 | Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific Corporation | 2011 | — |
| +4 | K133933 | Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific Corporation | 2014 | — |
| +5 | K171983 | Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory | Creo Medical, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 GAA? 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 GAA device
- #1 K223625 CapnoSpot™ Pneumothorax Decompression Indicatorscore 5.1 · 1 generation · no Class I recall
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? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K942301 | Microvasive Injection Gold Probe | 1994 | 6 |
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, K942301 (Boston Scientific Corp, 1994) has gone furthest, with 6 descendants of its own.
How does its category compare?
All GAA devicesGAA Needle, Aspiration And Injection, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAA
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GAA
Too few GAA 510(k)s in any year since 2007 to give a median.
Recalls per year · GAA
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAA
348in 2025
MAUDE reports naming product code GAA, 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 | 12 |
| 2008 | 0 | — | 1 | 32 |
| 2009 | 0 | — | 2 | 20 |
| 2010 | 0 | — | 2 | 18 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 24 |
| 2013 | 0 | — | 0 | 33 |
| 2014 | 0 | — | 0 | 24 |
| 2015 | 0 | — | 0 | 32 |
| 2016 | 0 | — | 0 | 45 |
| 2017 | 0 | — | 0 | 85 |
| 2018 | 0 | — | 0 | 122 |
| 2019 | 0 | — | 10 | 153 |
| 2020 | 0 | — | 0 | 102 |
| 2021 | 0 | — | 5 | 108 |
| 2022 | 0 | — | 2 | 74 |
| 2023 | 1 | — | 0 | 118 |
| 2024 | 0 | — | 0 | 181 |
| 2025 | 0 | — | 0 | 348 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K854238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K854238: Needle W/Stylet for Implantation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K854238
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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