510(k) · Cleared
ClearedOlypus FG Series Grasping 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 Aug 9, 1996 as substantially equivalent to K955066 (Olympus America, Inc., 1996) after a 42-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Aug 9, 1996
- Review
- 42 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955066 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK955066 Olympus FG Series Grasping ForcepsOlympus America, Inc. · 1996
- This deviceK962533 Olypus FG Series Grasping ForcepsOlympus America, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK202987 Rescue Pulmonary Grasping ForcepsAnrei Medical (Hangzhou) Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK200342 Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps…Olympus Medical Systems Corp. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955066 | Olympus FG Series Grasping Forceps | Olympus America, Inc. | 1996 | — |
| 0 (this device) | K962533 | Olypus FG Series Grasping Forceps | Olympus America, Inc. | 1996 | — |
| +1 | K202987 | Rescue Pulmonary Grasping Forceps | Anrei Medical (Hangzhou) Co., Ltd. | 2021 | — |
| +1 | K200342 | Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P… | Olympus Medical Systems Corp. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K955066 | Olympus FG Series Grasping ForcepsSummary page 1…for bronchoscopy Bronchoscope and Accessories 21 CFR 874.4680, Class Il Olympus pre-Amendment and 510(k) cleared grasping forceps Olympus FG Reusable Grasping Forceps (K955066) for Gl Barry Sands Olympus America, Inc. Endoscope Division 2 Corporate Center Drive Melville, NY 11747-3157 (516) 844-5474… | 1996 |
| * | — | Olympus pre-Amendment grasping forceps Named without a submission number |
What descends from it? (2)
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 FG series of grasping forceps are intended to be used to grasp tissue and/or retrieve foreign body and excised tissue endoscopically.
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/K962533 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962533: Olypus FG Series Grasping Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962533
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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