510(k) · Cleared
ClearedTrapsystem Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
H.S. Hospital Service S.R.L. · KNW Instrument, Biopsy
Cleared on Feb 5, 2002 as substantially equivalent to K952350 (Promedical, Ltd., 1995) after a 90-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Feb 5, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952350 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK952350 Jamshidi Style Biopsy Needle (Acri) (Biomid), Illinois Style Biopsy…Promedical, Ltd. · 1995
- This deviceK013692 Trapsystem SetH.S. Hospital Service S.R.L. · 2002
- Descendant · cites it directly · 0 of its ownK070179 Trokabone, Trokabone SternalPAJUNK GmbH Medizintechnologie · 2007
Most influential descendants
Showing 1 of 1 · See all- K070179Trokabone, Trokabone SternalPAJUNK GmbH Medizintechnologie · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952350 | Jamshidi Style Biopsy Needle (Acri) (Biomid), Illinois Style Biopsy Needle… | Promedical, Ltd. | 1995 | — |
| 0 (this device) | K013692 | Trapsystem Set | H.S. Hospital Service S.R.L. | 2002 | — |
| +1 | K070179 | Trokabone, Trokabone Sternal | PAJUNK GmbH Medizintechnologie | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | K952350 | Jamshidi Style Biopsy Needle (Acri) (Biomid), Illinois Style Biopsy Needle (Isan)Summary page 2…l wire with safety grip. The protective cover of cannula is made of polypropilene This type of device is also referred to Promedical Ltd, PRO-B biopsy Needle 510 (k) # K952350 We will incorporate all these features into our product, therefore providing the physician with a product that will safety assis… | 1995 |
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 |
|---|---|---|---|
| K070179 | Trokabone, Trokabone Sternal | 2007 | 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?
- Its one ancestor has no recall.
- Of its descendants, K070179 (PAJUNK GmbH Medizintechnologie, 2007) has gone furthest, with 0 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?
This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow
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/K013692 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013692: Trapsystem Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013692
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026