510(k) · Cleared
ClearedTemno Elite Biopsy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · KNW Instrument, Biopsy
Cleared on Aug 28, 2020 as substantially equivalent to K171953 (Bard Peripheral Vascular, Inc., 2017) after a 119-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Aug 28, 2020
- Review
- 119 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K950732 (1995). 6 ancestors in all, the oldest K922939 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backK950732 Manan Super-Core Biopsy NeedleManan Medical Products, Inc. · 1995
- 3 generations backK974814 Manan (TM) Super-Core Biopsy NeedlesMedical Device Technologies, Inc. · 1998 · Recalled
- 2 generations backK161409 M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial…Mermaid Medical A/S · 2016
- 1 generation backK171953 Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc. · 2017 · Recalled
- This deviceK201166 Temno Elite Biopsy SystemMerit Medical Systems, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950732 | Manan Super-Core Biopsy Needle | Manan Medical Products, Inc. | 1995 | — |
| −3 | K974814 | Manan (TM) Super-Core Biopsy Needles | Medical Device Technologies, Inc. | 1998 | 1 |
| −2 | K161409 | M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle… | Mermaid Medical A/S | 2016 | — |
| −1 | K171953 | Bard Mission Disposable Core Biopsy Instrument | Bard Peripheral Vascular, Inc. | 2017 | 3 |
| 0 (this device) | K201166 | Temno Elite Biopsy System | Merit Medical Systems, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2014 | 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.
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 25 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 3 other devices also cite its predicate K171953.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The Temno Elite Biopsy System is intended for use in obtaining biopsies from soft tissues such as liver, kidney, breast, prostate, spleen, lung, lymph nodes, thyroid, and various soft tissue masses. It is NOT intended for use in bone.
The Valved Coaxial Introducer Needle and Standard Coaxial Introducer Needles are intended for use as guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, prostate, spleen, lung, lymph nodes, thyroid, and various soft tissue masses. It is NOT intended for use in bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201166 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201166: Temno Elite Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201166
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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