510(k) · Cleared
ClearedOlympus FD-1/2-1 Hot Biopsy Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · KGE Forceps, Biopsy, Electric
Cleared on Jan 24, 1996 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Jan 24, 1996
- Review
- 79 days
- Class
- Class II
- Product code
- KGE
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 2 citing it directly.
- This deviceK955052 Olympus FD-1/2-1 Hot Biopsy ForcepsOlympus America, Inc. · 1996
- Descendant · cites it directly · 10 of its ownK062517 Electrosurgical Hemostatic Forceps SeriesOlympus Medical Systems Corporation · 2006
- Descendant · cites it directly · 4 of its ownK101657 Radial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps…Boston Scientific Corp · 2010
- Descendant · 2 generations on · 3 of its ownK151474 Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter…Fujifilm Medical System U.S.A., Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK161186 Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic…Fujifilm Medical Systems U.S.A, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK212423 EndoDrill® Model XBibbinstruments AB · 2023
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K062517Electrosurgical Hemostatic Forceps SeriesOlympus Medical Systems Corporation · 2006 · cites it directly10descendants
- K101657Radial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps Box 20; Radial Jaw 4…Boston Scientific Corp · 2010 · cites it directly4descendants
- K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc. · 2016 · 2 generations on3descendants
- K161186Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)Fujifilm Medical Systems U.S.A, Inc. · 2016 · 3 generations on2descendants
- K212423EndoDrill® Model XBibbinstruments AB · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955052 | Olympus FD-1/2-1 Hot Biopsy Forceps | Olympus America, Inc. | 1996 | — |
| +1 | K062517 | Electrosurgical Hemostatic Forceps Series | Olympus Medical Systems Corporation | 2006 | — |
| +1 | K101657 | Radial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps Box 20… | Boston Scientific Corp | 2010 | — |
| +2 | K151474 | Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) | Fujifilm Medical System U.S.A., Inc. | 2016 | — |
| +3 | K161186 | Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter… | Fujifilm Medical Systems U.S.A, Inc. | 2016 | — |
| +2 | K212423 | EndoDrill® Model X | Bibbinstruments AB | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGE? 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 KGE device
- #1 K251807 Single Use Electrosurgical Hemostatic Forceps…score 11.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 162 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, K062517 (Olympus Medical Systems Corporation, 2006) has gone furthest, with 10 descendants of its own.
How does its category compare?
All KGE devicesKGE Forceps, Biopsy, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGE
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGE
184in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGE
No recall names KGE since 2007.
Adverse event reports per year · KGE
10in 2025
MAUDE reports naming product code KGE, 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 | 0 | — | 0 | 4 |
| 2008 | 0 | — | 0 | 15 |
| 2009 | 2 | — | 0 | 75 |
| 2010 | 1 | — | 0 | 29 |
| 2011 | 0 | — | 0 | 51 |
| 2012 | 0 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 14 |
| 2014 | 1 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 3 | 102 | 0 | 9 |
| 2017 | 2 | — | 0 | 26 |
| 2018 | 3 | 184 | 0 | 26 |
| 2019 | 1 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 2 | — | 0 | 24 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 10 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K955052 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955052: Olympus FD-1/2-1 Hot Biopsy Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955052
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026