510(k) · Cleared
ClearedBiosuc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hakko Medical Co., Ltd. · KNW Instrument, Biopsy
Cleared on Apr 4, 2002 as substantially equivalent to K943651 (Manan Medical Products, Inc., 1994) and 2 other predicates after a 199-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Apr 4, 2002
- Review
- 199 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K831392 (1983). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK831392 Tru-Cut Biopsy/Aspira-Needle 2N2709Travenol Laboratories, S.A. · 1983
- This deviceK013108 BiosucHakko Medical Co., Ltd. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831392 | Tru-Cut Biopsy/Aspira-Needle 2N2709 | Travenol Laboratories, S.A. | 1983 | — |
| 0 (this device) | K013108 | Biosuc | Hakko Medical Co., Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 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 KNW? 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 KNW device
- #1 K260572 Marrow Marxmanscore 14.5 · 10 generations · 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 |
|---|---|---|---|
| * | K943651 | Techna-Cut Aspiration NeedleSummary page 1…logy-urology biopsy instrument). Product Code: KNW 3. STATEMENT OF SUBSTANTIAL EQUIVALENCE: Predicate Devices: Manan Medical Products, Inc. Westcott Aspiration Needle K943651 Travenol Lab. Allegiance Aspiration Needle K831392 Daum GMBH - Daum Aspiration Biopsy Needle K974575 The Biosuc Fine Aspiration… | 1994 |
| * | K831392 | Tru-Cut Biopsy/Aspira-Needle 2N2709Summary page 1…3. STATEMENT OF SUBSTANTIAL EQUIVALENCE: Predicate Devices: Manan Medical Products, Inc. Westcott Aspiration Needle K943651 Travenol Lab. Allegiance Aspiration Needle K831392 Daum GMBH - Daum Aspiration Biopsy Needle K974575 The Biosuc Fine Aspiration Cytology Needle is substantially equivalent to the… | 1983 |
| * | K974575 | Daum Aspirationbiopsy NeedleSummary page 1…te Devices: Manan Medical Products, Inc. Westcott Aspiration Needle K943651 Travenol Lab. Allegiance Aspiration Needle K831392 Daum GMBH - Daum Aspiration Biopsy Needle K974575 The Biosuc Fine Aspiration Cytology Needle is substantially equivalent to the referenced predicated devices in that it is simila… | 1998 |
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?
- None of the 3 ancestors has a recall.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNW
1in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · KNW
1,667in 2025
MAUDE reports naming product code KNW, 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 | 6 | 94 | 1 | 766 |
| 2008 | 4 | 53 | 7 | 363 |
| 2009 | 6 | 35 | 3 | 351 |
| 2010 | 3 | 57 | 2 | 162 |
| 2011 | 10 | 64 | 5 | 67 |
| 2012 | 7 | 94 | 1 | 93 |
| 2013 | 3 | 100 | 1 (1) | 98 |
| 2014 | 8 | 95 | 3 | 193 |
| 2015 | 10 | 106 | 0 | 591 |
| 2016 | 9 | 127 | 5 | 297 |
| 2017 | 8 | 90 | 1 | 760 |
| 2018 | 7 | 71 | 0 | 1,012 |
| 2019 | 5 | 94 | 4 | 4,195 |
| 2020 | 8 | 92 | 0 | 5,120 |
| 2021 | 9 | 54 | 3 | 1,020 |
| 2022 | 8 | 203 | 3 | 535 |
| 2023 | 7 | 164 | 2 | 931 |
| 2024 | 5 | 114 | 1 | 1,283 |
| 2025 | 12 | 178 | 0 | 1,667 |
| 2026 | 7 | 29 | 4 (3) | — |
What is it indicated for?
The BioSuc Fine Aspiration Cytology Needle is indicated for the biopsy of tumors in the Thyroid, Breast or Lymph node.
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/K013108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013108: Biosuc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013108
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026