510(k) · Cleared
ClearedOlympus Disposable Biopsy Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Feb 27, 1995 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 9 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- Feb 27, 1995
- Review
- 14 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly. 3 of the 9 devices in this family, counting this one, have a Class I recall.
- This deviceK950636 Olympus Disposable Biopsy ForcepsOlympus America, Inc. · 1995
- Descendant · cites it directly · 7 of its ownK172726 EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use…Olympus Medical Systems Corp. · 2018 · Recalled
- Descendant · 2 generations on · 2 of its ownK183419 EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK201758 EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III…Olympus Medical Systems Corp. · 2021 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK192164 Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding…Olympus Medical Systems Corp. · 2020
- Descendant · 3 generations on · 0 of its ownK250862 Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii…Olympus Medical Systems Corp. · 2025 · Recalled (Class I)
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K172726EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433DOlympus Medical Systems Corp. · 2018 · cites it directly7descendants
- K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · 2 generations on2descendants
- K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope…Olympus Medical Systems Corp. · 2021 · 3 generations on1descendant
- K192164Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DROlympus Medical Systems Corp. · 2020 · 2 generations on1descendant
- K250862Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope…Olympus Medical Systems Corp. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950636 | Olympus Disposable Biopsy Forceps | Olympus America, Inc. | 1995 | — |
| +1 | K172726 | EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy… | Olympus Medical Systems Corp. | 2018 | 2 |
| +2 | K183419 | EVIS EXERA III Bronchovideoscope Olympus BF-XT190 | Olympus Medical Systems Corp. | 2019 | Class I |
| +3 | K201758 | EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III… | Olympus Medical Systems Corp. | 2021 | Class I |
| +2 | K192164 | Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR | Olympus Medical Systems Corp. | 2020 | — |
| +3 | K250862 | Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii… | Olympus Medical Systems Corp. | 2025 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 1 |
| 2020 | 2 | 0 |
| 2021 | 2 | 1 |
| 2025 | 2 | 1 |
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.
3 devices in this family have a Class I recall. 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 EOQ device
- #1 K223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu®…score 18.4 · 11 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? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172726 | EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D | 2018 | 7 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
- K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190Olympus Medical Systems Corp. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K250862Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope (Olympus BF-P190)…Olympus Medical Systems Corp. · 2025 · 3 generations on · ◆ in the 2025 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K172726 (Olympus Medical Systems Corp., 2018) has gone furthest, with 7 descendants of its own.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EOQ
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOQ
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOQ
25in 2025
Class I (28 since 2007) Class II/III not classified
Adverse event reports per year · EOQ
6,546in 2025
MAUDE reports naming product code EOQ, 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 | 2 | — | 0 | 39 |
| 2008 | 2 | — | 0 | 87 |
| 2009 | 3 | 24 | 0 | 114 |
| 2010 | 0 | — | 0 | 100 |
| 2011 | 0 | — | 1 | 96 |
| 2012 | 2 | — | 4 | 93 |
| 2013 | 4 | 178 | 0 | 93 |
| 2014 | 3 | 302 | 0 | 98 |
| 2015 | 6 | 206 | 0 | 132 |
| 2016 | 3 | 262 | 1 | 297 |
| 2017 | 4 | 136 | 0 | 337 |
| 2018 | 7 | 212 | 0 | 279 |
| 2019 | 11 | 147 | 1 | 654 |
| 2020 | 10 | 103 | 1 | 515 |
| 2021 | 15 | 169 | 9 | 1,358 |
| 2022 | 11 | 134 | 5 | 2,541 |
| 2023 | 12 | 160 | 18 (4) | 5,064 |
| 2024 | 13 | 130 | 4 | 6,051 |
| 2025 | 20 | 147 | 25 (24) | 6,546 |
| 2026 | 9 | 206 | 0 | — |
https://510kreport.com/device/K950636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950636: Olympus Disposable Biopsy Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950636
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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