510(k) · Cleared
ClearedSingle Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Dec 17, 2020 as substantially equivalent to K962533 (Olympus America, Inc., 1996) and 1 other predicate after a 310-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Dec 17, 2020
- Review
- 310 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K931154 (1993). 11 ancestors in all, the oldest K850978 (1985). No later device cites it as a predicate yet.
- Root · 4 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 3 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 2 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 1 generation backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- This deviceK200342 Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps…Olympus Medical Systems Corp. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −3 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −2 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −1 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| 0 (this device) | K200342 | Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P… | Olympus Medical Systems Corp. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 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 |
|---|---|---|---|
| * | K962533 | Olypus FG Series Grasping ForcepsSummary page 7…Device name 510(k) Submitter 510(k) No. Olympus FG Series Reusable OLYMPUS MEDICAL K962533 Grasping Forceps SYSTEMS CORP. (FG-14P-1/FG-26C-1/FG-20P-1/FG-3 2L-1/FG-4L-1) Grasping Forceps FG-53SX-1… | 1996 |
| * | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary EquipmentSummary page 7…ps SYSTEMS CORP. (FG-14P-1/FG-26C-1/FG-20P-1/FG-3 2L-1/FG-4L-1) Grasping Forceps FG-53SX-1 OLYMPUS MEDICAL K013591 SYSTEMS CORP. 4. DEVICE DESCRIPTION ◼ General Description of the subject device FG… | 2001 |
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 27 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 4 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K962533.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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?
This instrument has been designed to be used with an Olympus endoscope to retrieve foreign bodies or resected tissue from the nasal lumens and airway anatomy (including nasopharynx and trachea). This instrument has been designed to be used with an Olympus endoscope to retrieve foreign bodies or resected tissue from the airways and tracheobronchial tree. This instrument has been designed to be used with an Olympus endoscope to retrieve foreign bodies or…
Read the full statement (129 words)
This instrument has been designed to be used with an Olympus endoscope to retrieve foreign bodies or resected tissue from the nasal lumens and airway anatomy (including nasopharynx and trachea).
This instrument has been designed to be used with an Olympus endoscope to retrieve foreign bodies or resected tissue from the airways and tracheobronchial tree.
This instrument has been designed to be used with an Olympus endoscope to retrieve foreign bodies or resected tissue from the airways and tracheobronchial tree.
This instrument has been designed to be used with an Olympus endoscope to retrieve foreign bodies from the nasal lumens and airway anatomy (including nasopharynx and trachea).
This instrument has been designed to be used with an Olympus endoscope to retrieve foreign bodies from the airways and tracheobronchial tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200342: Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200342
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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