510(k) · Cleared
ClearedMri Chiba,Spinal,Breast Localization,Automatic Cutting Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Manan Medical Products, Inc. · KNW Instrument, Biopsy
Cleared on Feb 6, 1998 as substantially equivalent to K962977 (Manan Medical Products, Inc., 1997) after a 16-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.
- Decided
- Feb 6, 1998
- Review
- 16 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962977 (1997). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK962977 Mri Compatible Biopsy NeedlesManan Medical Products, Inc. · 1997
- This deviceK980211 Mri Chiba,Spinal,Breast Localization,Automatic Cutting NeedlesManan Medical Products, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK063697 Special Sprotte, Chiba, DR Steinhoff KitPAJUNK GmbH Medizintechnologie · 2007
- Descendant · 2 generations on · 0 of its ownK113209 Chiba SonoPajunk GmbH · 2011
- Descendant · cites it directly · 0 of its ownK052435 Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962977 | Mri Compatible Biopsy Needles | Manan Medical Products, Inc. | 1997 | — |
| 0 (this device) | K980211 | Mri Chiba,Spinal,Breast Localization,Automatic Cutting Needles | Manan Medical Products, Inc. | 1998 | — |
| +1 | K063697 | Special Sprotte, Chiba, DR Steinhoff Kit | PAJUNK GmbH Medizintechnologie | 2007 | — |
| +2 | K113209 | Chiba Sono | Pajunk GmbH | 2011 | — |
| +1 | K052435 | Pneumrx Family of Biopsy Needles and Kits | Pneumrx, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K962977 | Mri Compatible Biopsy NeedlesSummary page 1…st Localization Needle MRI Simon Breast Localization Needle Hand-held biopsy needles. §878.4800 - Manual Surgical Instruments Product Name 310(k) No, MRI Chiba Needle K962977 MRI Spinal Needle MRI Automatic Cutting Needle MRI General Purpose Introducer Needle MRI Techna-Cut Biopsy Needle MRI Super-C… | 1997 |
What descends from it? (3)
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?
- Its one ancestor has no recall.
- Of its descendants, K063697 (PAJUNK GmbH Medizintechnologie, 2007) has gone furthest, with 1 descendant of its own.
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?
These needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues through a combination of cutting and/or aspirating.
The breast localization needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain breast lesion tissue.
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/K980211 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980211: Mri Chiba,Spinal,Breast Localization,Automatic Cutting Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980211
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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