510(k) · Cleared
ClearedSingle Use Hot Biopsy Forceps FD-231
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · QEC Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree
Cleared on Nov 30, 2018 as substantially equivalent to K160625 (Micro-Tech (Nanjing) Co., Ltd., 2016) after a 382-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Nov 30, 2018
- Review
- 382 days
- Class
- Class II
- Product code
- QEC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K874314 (1987). No later device cites it as a predicate yet.
- Root · 3 generations backK874314 Wilson-Cook Biopsy ForcepsWilson-Cook Medical, Inc. · 1987
- 2 generations backK953355 Gip/Meid-Globe Hot Biopsy ForcepsMedi-Globe Corp. · 1996
- 1 generation backK160625 Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd. · 2016
- This deviceK173495 Single Use Hot Biopsy Forceps FD-231Olympus Medical Systems Corp. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K874314 | Wilson-Cook Biopsy Forceps | Wilson-Cook Medical, Inc. | 1987 | — |
| −2 | K953355 | Gip/Meid-Globe Hot Biopsy Forceps | Medi-Globe Corp. | 1996 | — |
| −1 | K160625 | Disposable Hot Biopsy Forceps | Micro-Tech (Nanjing) Co., Ltd. | 2016 | — |
| 0 (this device) | K173495 | Single Use Hot Biopsy Forceps FD-231 | Olympus Medical Systems Corp. | 2018 | — |
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 QEC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K160625 | Disposable Hot Biopsy ForcepsSummary page 5…Biopsy Forceps Forceps FB-433D COAGULATION ELECTRODE K number K160625 K172726 K971328 Classification II II II 5.4… | 2016 |
| † | K172726 | EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D | 2018 |
| † | K971328 | Olympus CD-6C-1 Coagulation Electrode | 1997 |
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 31 years and passes through 4 companies; a new generation was cleared every 8.3 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K160625.
How does its category compare?
All QEC devicesQEC Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QEC
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · QEC
Too few QEC 510(k)s in any year since 2007 to give a median.
Recalls per year · QEC
No recall names QEC since 2007.
Adverse event reports per year · QEC
No MAUDE report names QEC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This instrument has been designed to be used with an Olympus endoscope to electrosurgically collect tissue, to electrosurgically cauterize, or to perform electrosurgical hemostasis within the tracheobronchial tree.
The product is only intended for adult populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173495: Single Use Hot Biopsy Forceps FD-231.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173495
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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