510(k) · Cleared
ClearedModification to Temno Biopsy Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allegiance Healthcare Corp. · FCG Biopsy Needle
Cleared on Jan 15, 2003 after a 30-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jan 15, 2003
- Review
- 30 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK024120 Modification to Temno Biopsy NeedlesAllegiance Healthcare Corp. · 2003
- Descendant · cites it directly · 1 of its ownK080095 Coramate/Spirotome SystemMedinvents · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK190378 Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14…Bioncise NV · 2019
- Descendant · cites it directly · 0 of its ownK080674 Pajunk's Primocut Disposable Biopsy SystemPAJUNK GmbH Medizintechnologie · 2008
Most influential descendants
Showing 3 of 3 · See all- K080095Coramate/Spirotome SystemMedinvents · 2008 · cites it directly1descendant
- K190378Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome…Bioncise NV · 2019 · 2 generations on0descendants
- K080674Pajunk's Primocut Disposable Biopsy SystemPAJUNK GmbH Medizintechnologie · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024120 | Modification to Temno Biopsy Needles | Allegiance Healthcare Corp. | 2003 | — |
| +1 | K080095 | Coramate/Spirotome System | Medinvents | 2008 | 1 |
| +2 | K190378 | Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge… | Bioncise NV | 2019 | — |
| +1 | K080674 | Pajunk's Primocut Disposable Biopsy System | PAJUNK GmbH Medizintechnologie | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2019 | 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 FCG? 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 FCG device
- #1 K250994 ClearTip FNA and FNB Typesscore 13.2 · 12 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 |
|---|---|---|---|
| * | — | Disposable Semi-Automated Temno® Biopsy Device Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K080095 (Medinvents, 2008) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FCG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FCG
82in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FCG
5in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCG
632in 2025
MAUDE reports naming product code FCG, 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 | 4 | 32 | 0 | 11 |
| 2008 | 1 | — | 19 | 115 |
| 2009 | 4 | 87 | 5 | 270 |
| 2010 | 3 | 18 | 4 | 73 |
| 2011 | 1 | — | 2 | 71 |
| 2012 | 0 | — | 0 | 107 |
| 2013 | 1 | — | 0 | 130 |
| 2014 | 5 | 88 | 0 | 154 |
| 2015 | 4 | 91 | 0 | 124 |
| 2016 | 3 | 63 | 0 | 191 |
| 2017 | 3 | 166 | 0 | 273 |
| 2018 | 6 | 140 | 0 | 282 |
| 2019 | 0 | — | 0 | 229 |
| 2020 | 1 | — | 0 | 240 |
| 2021 | 1 | — | 5 | 290 |
| 2022 | 2 | — | 0 | 302 |
| 2023 | 4 | 82 | 0 | 428 |
| 2024 | 1 | — | 0 | 446 |
| 2025 | 2 | — | 0 | 632 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This biopsy device is used to remove, by cutting, a specimen of tissue for microscopic evaluation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024120 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024120: Modification to Temno Biopsy Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024120
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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