510(k) · Cleared
ClearedOlympus FB Series 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 Jul 30, 1996 as substantially equivalent to K955065 (Olympus America, Inc., 1996) after a 29-day review. Its family tree reaches back 1 generation to 1996. 9 later devices descend from it.
- Decided
- Jul 30, 1996
- Review
- 29 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955065 (1996). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK955065 Olympus FB Series Biopsy ForcepsOlympus America, Inc. · 1996
- This deviceK962555 Olympus FB Series Biopsy ForcepsOlympus America, Inc. · 1996
- Descendant · cites it directly · 7 of its ownK173760 Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 5 of its ownK193534 Monarch PlatformAuris Health, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 2 of its ownK211493 Monarch PlatformAuris Health, Inc. · 2021 · Recalled
- Descendant · 4 generations on · 1 of its ownK243219 MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2025 · Recalled
- Descendant · 3 generations on · 1 of its ownK203614 Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K173760Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc. · 2018 · cites it directly7descendants
- K193534Monarch PlatformAuris Health, Inc. · 2020 · 2 generations on5descendants
- K211493Monarch PlatformAuris Health, Inc. · 2021 · 3 generations on2descendants
- K243219MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2025 · 4 generations on1descendant
- K203614Monarch BronchoscopeAuris Health, Inc., A Johnson and Johnson Family Company · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955065 | Olympus FB Series Biopsy Forceps | Olympus America, Inc. | 1996 | — |
| 0 (this device) | K962555 | Olympus FB Series Biopsy Forceps | Olympus America, Inc. | 1996 | — |
| +1 | K173760 | Monarch Endoscopy Platform (Monarch Platform) | Auris Surgical Robotics, Inc. | 2018 | 1 |
| +2 | K193534 | Monarch Platform | Auris Health, Inc. | 2020 | 4 |
| +3 | K211493 | Monarch Platform | Auris Health, Inc. | 2021 | 2 |
| +4 | K243219 | MONARCH™ Platform (MON-000008) | Auris Health, Inc. | 2025 | 1 |
| +3 | K203614 | Monarch Bronchoscope | Auris Health, Inc., A Johnson and Johnson Family Company | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 EOQ? 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? (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 |
|---|---|---|---|
| * | K955065 | Olympus FB Series Biopsy ForcepsSummary page 1…Accessories 21 CFR 884.4680, Class Il Predicate Device: Olympus pre-Amendment and 510(k) cleared reusable biopsy forceps. Olympus FB Series of Reusable Biopsy Forceps (K955065) Contact Person: Barry Sands Olympus America, Inc. Endoscope Division 2 Corporate Center Drive Melville, NY 11747-3157 (516) 844… | 1996 |
What descends from it? (9)
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?
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 | — |
What is it indicated for?
The Olympus biopsy forceps are intended to be used for the collection of tissue samples under endoscopic observation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962555 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962555: Olympus FB Series Biopsy Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962555
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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