510(k) · Cleared
ClearedChiba Sono
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pajunk GmbH · KNW Instrument, Biopsy
Cleared on Nov 21, 2011 as substantially equivalent to K063697 (PAJUNK GmbH Medizintechnologie, 2007) after a 21-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Nov 21, 2011
- Review
- 21 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K962977 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK962977 Mri Compatible Biopsy NeedlesManan Medical Products, Inc. · 1997
- 2 generations backK980211 Mri Chiba,Spinal,Breast Localization,Automatic Cutting NeedlesManan Medical Products, Inc. · 1998
- 1 generation backK063697 Special Sprotte, Chiba, DR Steinhoff KitPAJUNK GmbH Medizintechnologie · 2007
- This deviceK113209 Chiba SonoPajunk GmbH · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962977 | Mri Compatible Biopsy Needles | Manan Medical Products, Inc. | 1997 | — |
| −2 | 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 | — |
| 0 (this device) | K113209 | Chiba Sono | Pajunk GmbH | 2011 | — |
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 |
|---|---|---|---|
| * | K063697 | Special Sprotte, Chiba, DR Steinhoff KitSummary page 1…gulatory Class: 11 Panel: Gastroenterology/Urology Predicate Device: K063697 SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT… | 2007 |
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 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. 2011, 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?
PAJUNKos soft tissue biopsy, puncture and aspiration cannulas and needles are intended for obtaining biopsies from soft tissues, for use in puncturing and for aspiration.
They are not appropriate for bone biopsies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113209: Chiba Sono.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113209
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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