510(k) · Cleared
ClearedHS Nota
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
H.S. Hospital Services S.P.A. · FCG Biopsy Needle
Cleared on Oct 10, 2014 as substantially equivalent to K002944 (H.S. Hospital Service S.R.L., 2000) after a 471-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Oct 10, 2014
- Review
- 471 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002944 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK002944 Precisa Biopsy NeedleH.S. Hospital Service S.R.L. · 2000
- This deviceK131925 HS NotaH.S. Hospital Services S.P.A. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002944 | Precisa Biopsy Needle | H.S. Hospital Service S.R.L. | 2000 | — |
| 0 (this device) | K131925 | HS Nota | H.S. Hospital Services S.P.A. | 2014 | — |
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 FCG? 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 FCG device
- #1 K250994 ClearTip FNA and FNB Typesscore 13.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K002944 | Precisa Biopsy NeedleSummary page 4…he HS Nota is substantially equivalent to the following legally marketed device: • HS Hospital Service S.p.A. “PRECISA” biopsy needle cleared and marketed under K002944. 4. Intended use HS NOTA is an automatic biopsy needle and can be used in Fluoroscopic, CT and Mammographic procedures to obtai… | 2000 |
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?
- Its one ancestor has no recall.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FCG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FCG
82in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FCG
5in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCG
632in 2025
MAUDE reports naming product code FCG, 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 | 4 | 32 | 0 | 11 |
| 2008 | 1 | — | 19 | 115 |
| 2009 | 4 | 87 | 5 | 270 |
| 2010 | 3 | 18 | 4 | 73 |
| 2011 | 1 | — | 2 | 71 |
| 2012 | 0 | — | 0 | 107 |
| 2013 | 1 | — | 0 | 130 |
| 2014 | 5 | 88 | 0 | 154 |
| 2015 | 4 | 91 | 0 | 124 |
| 2016 | 3 | 63 | 0 | 191 |
| 2017 | 3 | 166 | 0 | 273 |
| 2018 | 6 | 140 | 0 | 282 |
| 2019 | 0 | — | 0 | 229 |
| 2020 | 1 | — | 0 | 240 |
| 2021 | 1 | — | 5 | 290 |
| 2022 | 2 | — | 0 | 302 |
| 2023 | 4 | 82 | 0 | 428 |
| 2024 | 1 | — | 0 | 446 |
| 2025 | 2 | — | 0 | 632 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
HS NOTA is an automatic biopsy needle and can be used in Fluoroscopic, CT and Mammographic procedures to obtain biopsies of soft tissue including those from prostate, kidney, breast and liver.
The device is for prescription use, to be used by physicians in hospitals and clinics.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131925 · printed Nov 3, 2026
Cite this page
510(k) Report. “K131925: HS Nota.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K131925
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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