510(k) · Cleared
ClearedDisposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · KGE Forceps, Biopsy, Electric
Cleared on Oct 7, 2025 as substantially equivalent to K101657 (Boston Scientific Corp, 2010) after a 258-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Oct 7, 2025
- Review
- 258 days
- Class
- Class II
- Product code
- KGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910964 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK910964 Hot Biopsy ForcepsSymbiosis Corp. · 1991
- 1 generation backK101657 Radial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps…Boston Scientific Corp · 2010
- This deviceK250187 Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy…Olympus Medical Systems Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910964 | Hot Biopsy Forceps | Symbiosis Corp. | 1991 | — |
| −1 | K101657 | Radial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps Box 20… | Boston Scientific Corp | 2010 | — |
| 0 (this device) | K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | Olympus Medical Systems Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 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? (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 |
|---|---|---|---|
| * | K101657 | Radial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps Box 20; Radial Jaw 4…Summary page 5…3. Predicate Device Information Device Name 510(k) Submitter 510(k) Number Radial Jaw 4 Hot Biopsy Boston Scientific Corp. K101657 Forceps 4. Device Description The Disposable Hot Biopsy Forceps have been designed to collect tissue endoscopically wi… | 2010 |
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 34 years and passes through 3 companies; a new generation was cleared every 19.4 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K101657.
How does its category compare?
All KGE devicesKGE Forceps, Biopsy, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The DISPOSABLE HOT BIOPSY FORCEPS FD-210U/FD-230U are intended to be used to collect tissue samples within the digestive tract using high-frequency current under endoscopic observation in combination with an endoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250187: Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250187
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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