510(k) · Cleared
ClearedAccucore Core Biopsy Needle Catalog Codes:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inrad · KNW Instrument, Biopsy
Cleared on Jun 22, 1998 as substantially equivalent to K974446 (Manan Medical Products, Inc., 1998) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it.
- Decided
- Jun 22, 1998
- Review
- 83 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K895897 (1989). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK895897 Manan Prostatic Biopsy NeedleManan Medical Products, Inc. · 1989
- This deviceK981166 Accucore Core Biopsy Needle Catalog Codes:581014, 581614, 581618…Inrad · 1998
- Descendant · cites it directly · 0 of its ownK052435 Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK013109 SonopsyHakko Medical Co., Ltd. · 2002
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895897 | Manan Prostatic Biopsy Needle | Manan Medical Products, Inc. | 1989 | — |
| 0 (this device) | K981166 | Accucore Core Biopsy Needle Catalog Codes:581014, 581614, 581618, 582018… | Inrad | 1998 | — |
| +1 | K052435 | Pneumrx Family of Biopsy Needles and Kits | Pneumrx, Inc. | 2005 | — |
| +1 | K013109 | Sonopsy | Hakko Medical Co., Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 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? (2)
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 |
|---|---|---|---|
| * | K974446 | Manan Automatic Cutting NeedleSummary page 1…INDICATIONS: The indications or intended use for the Inrad Accucore Biopsy Needle as well as the predicate device, Manan Medical Products, Inc. Automatic Cutting Needle (K 974446)/(K895897) are the same. Both have the same indications, which is for obtaining soft tissue biopsies with a commercially availabl… | 1998 |
| * | K895897 | Manan Prostatic Biopsy NeedleSummary page 1…: The indications or intended use for the Inrad Accucore Biopsy Needle as well as the predicate device, Manan Medical Products, Inc. Automatic Cutting Needle (K 974446)/(K895897) are the same. Both have the same indications, which is for obtaining soft tissue biopsies with a commercially available biopsy i… | 1989 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 Accucore Biopsy Needle can be used for obtaining core and/or aspiration biopsies of various tissues (prostate, lung, liver, spleen, thyroid, adrenals, abdominal soft tissue masses, breast). For breast biopsy this product is for diagnosis only - not for therapeutic use.
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/K981166 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981166: Accucore Core Biopsy Needle Catalog Codes:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981166
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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