510(k) · Cleared
ClearedSpecial Sprotte, Chiba, DR Steinhoff Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
PAJUNK GmbH Medizintechnologie · KNW Instrument, Biopsy
Cleared on Feb 14, 2007 as substantially equivalent to K980211 (Manan Medical Products, Inc., 1998) after a 63-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Feb 14, 2007
- Review
- 63 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K962977 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK962977 Mri Compatible Biopsy NeedlesManan Medical Products, Inc. · 1997
- 1 generation backK980211 Mri Chiba,Spinal,Breast Localization,Automatic Cutting NeedlesManan Medical Products, Inc. · 1998
- This deviceK063697 Special Sprotte, Chiba, DR Steinhoff KitPAJUNK GmbH Medizintechnologie · 2007
- Descendant · cites it directly · 0 of its ownK113209 Chiba SonoPajunk GmbH · 2011
Most influential descendants
Showing 1 of 1 · See all- K113209Chiba SonoPajunk GmbH · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K063697 | Special Sprotte, Chiba, DR Steinhoff Kit | PAJUNK GmbH Medizintechnologie | 2007 | — |
| +1 | K113209 | Chiba Sono | Pajunk GmbH | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K980211 | Mri Chiba,Spinal,Breast Localization,Automatic Cutting NeedlesSummary page 1…ssification Panel: Gastroenterology/ Urology Additional Review Advisory Committee: General & Plastic Surgery Predicate Devices: 1. K980211 Manan MRI Chiba, spinal, breast localization etc. PMN… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113209 | Chiba Sono | 2011 | 0 |
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K113209 (Pajunk GmbH, 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K980211.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
Pajunks soft tissue biopsy, puncture and aspiration cannulas and needles listed above are intended for obtaining biopsies from soft tissues, for use in puncturing and for aspiration. They are not appropriate for bone biopsies. Pajunks soft tissue puncture and aspiration Kit acc. Steinhoff is intended for use in puncturing and aspiring for soft tissue biopsy. Pajunks breast localization cannulas/ needles can be used in Mammographic procedures to obtain…
Read the full statement (219 words)
Pajunks soft tissue biopsy, puncture and aspiration cannulas and needles listed above are intended for obtaining biopsies from soft tissues, for use in puncturing and for aspiration. They are not appropriate for bone biopsies.
Pajunks soft tissue puncture and aspiration Kit acc. Steinhoff is intended for use in puncturing and aspiring for soft tissue biopsy.
Pajunks breast localization cannulas/ needles can be used in Mammographic procedures to obtain breast lesion tissue.
Pajunks Breast localization cannulas/ needles are intended for diagnostic sampling of breast tissue during breast biopsy procedures. They are to be used for diagnostic purposes only and are not intended for therapeutic uses,
The Breast localization cannulas/ needles are indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
This device is not indicated fo' use under MR based imaging technologies, such as MRI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063697: Special Sprotte, Chiba, DR Steinhoff Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063697
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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