510(k) · Cleared
ClearedMri Compatible Biopsy 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 Oct 9, 1997 after a 435-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Oct 9, 1997
- Review
- 435 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK962977 Mri Compatible Biopsy NeedlesManan Medical Products, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK980211 Mri Chiba,Spinal,Breast Localization,Automatic Cutting NeedlesManan Medical Products, Inc. · 1998
- Descendant · 2 generations on · 1 of its ownK063697 Special Sprotte, Chiba, DR Steinhoff KitPAJUNK GmbH Medizintechnologie · 2007
- Descendant · 3 generations on · 0 of its ownK113209 Chiba SonoPajunk GmbH · 2011
- Descendant · 2 generations on · 0 of its ownK052435 Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc. · 2005
Most influential descendants
Showing 4 of 4 · See all- K980211Mri Chiba,Spinal,Breast Localization,Automatic Cutting NeedlesManan Medical Products, Inc. · 1998 · cites it directly3descendants
- K063697Special Sprotte, Chiba, DR Steinhoff KitPAJUNK GmbH Medizintechnologie · 2007 · 2 generations on1descendant
- K113209Chiba SonoPajunk GmbH · 2011 · 3 generations on0descendants
- K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962977 | Mri Compatible Biopsy Needles | Manan Medical Products, Inc. | 1997 | — |
| +1 | K980211 | Mri Chiba,Spinal,Breast Localization,Automatic Cutting Needles | Manan Medical Products, Inc. | 1998 | — |
| +2 | K063697 | Special Sprotte, Chiba, DR Steinhoff Kit | PAJUNK GmbH Medizintechnologie | 2007 | — |
| +3 | K113209 | Chiba Sono | Pajunk GmbH | 2011 | — |
| +2 | K052435 | Pneumrx Family of Biopsy Needles and Kits | Pneumrx, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980211 | Mri Chiba,Spinal,Breast Localization,Automatic Cutting Needles | 1998 | 3 |
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, K980211 (Manan Medical Products, Inc., 1998) has gone furthest, with 3 descendants 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?
Needles can be used in MRI, Flouroscopic, CT and Mammographic procedures
for obtaining biopsies of various tissues.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962977 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962977: Mri Compatible Biopsy Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962977
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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