510(k) · Cleared
ClearedDisposable Grasping Forceps FG-52D/FG-54D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · KTI Bronchoscope Accessory
Cleared on Mar 31, 2025 as substantially equivalent to K020765 (Boston Scientific Corp, 2002) after a 61-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Mar 31, 2025
- Review
- 61 days
- Class
- Class II
- Product code
- KTI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K962367 (1996). No later device cites it as a predicate yet.
- Root · 2 generations backK962367 Olympus Basket GraspersOlympus America, Inc. · 1996
- 1 generation backK020765 Microvasive Zero Tip Airway Retrieval Basket, Models M00513200 and…Boston Scientific Corp · 2002
- This deviceK250263 Disposable Grasping Forceps FG-52D/FG-54DOlympus Medical Systems Corp. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962367 | Olympus Basket Graspers | Olympus America, Inc. | 1996 | — |
| −1 | K020765 | Microvasive Zero Tip Airway Retrieval Basket, Models M00513200 and M00513210 | Boston Scientific Corp | 2002 | — |
| 0 (this device) | K250263 | Disposable Grasping Forceps FG-52D/FG-54D | Olympus Medical Systems Corp. | 2025 | — |
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 KTI? 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 KTI device
- #1 K261274 EchoTip Ultra® Endobronchial HD Ultrasound…score 15.0 · 12 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 |
|---|---|---|---|
| * | K020765 | Microvasive Zero Tip Airway Retrieval Basket, Models M00513200 and M00513210Summary page 5…Device Substantial equivalence is claimed to the following device: • Microvasive Zero Tip Airway Retrieval Basket, Models M00513200 and M00513210, K020765, Boston Scientific Corp. IV. Device Description The Disposable Grasping Forceps FG-52D/FG-54D are designed to retrieve f… | 2002 |
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 29 years and passes through 3 companies; a new generation was cleared every 23.0 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K020765.
How does its category compare?
All KTI devicesKTI Bronchoscope Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · KTI
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTI
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTI
198in 2025
MAUDE reports naming product code KTI, 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 | 0 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 11 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 1 | — | 0 | 17 |
| 2012 | 0 | — | 1 | 12 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 3 | 140 | 0 | 7 |
| 2017 | 3 | 115 | 0 | 9 |
| 2018 | 1 | — | 1 | 14 |
| 2019 | 1 | — | 0 | 27 |
| 2020 | 1 | — | 0 | 37 |
| 2021 | 1 | — | 0 | 47 |
| 2022 | 3 | 137 | 0 | 131 |
| 2023 | 4 | 168 | 0 | 130 |
| 2024 | 0 | — | 0 | 149 |
| 2025 | 5 | 61 | 0 | 198 |
| 2026 | 3 | 98 | 0 | — |
What is it indicated for?
The Disposable Grasping Forceps FG-52D/54D are intended to be used to retrieve foreign bodies, calculus or tissue specimens from the tracheobronchial tree in combination with an endoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250263: Disposable Grasping Forceps FG-52D/FG-54D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250263
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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