510(k) · Cleared
ClearedXBO1-824-18/19/20 Biopsy Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Olympus Optical Co. · OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered
Cleared on Sep 25, 2001 as substantially equivalent to K911448 (Triton Technology, Inc., 1991) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Sep 25, 2001
- Review
- 85 days
- Class
- Class II
- Product code
- OCZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K911448 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK911448 Multiple Biopsy Device-MBXTriton Technology, Inc. · 1991
- This deviceK012074 XBO1-824-18/19/20 Biopsy ForcepsThe Olympus Optical Co. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911448 | Multiple Biopsy Device-MBX | Triton Technology, Inc. | 1991 | — |
| 0 (this device) | K012074 | XBO1-824-18/19/20 Biopsy Forceps | The Olympus Optical Co. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 OCZ? 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 OCZ device
- #1 K252800 KARL STORZ Endoscopic Accessories for Urologyscore 11.4 · 1 generation · 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 |
|---|---|---|---|
| * | K911448 | Multiple Biopsy Device-MBXSummary page 5…21CFR 876.1500 /(0 /A0 7Y C. Predicate Devices: _ 7 4 Rog > Model - Device Description & Manufacturer 510(k)#/ Date Cleared Multiple Biopsy Device MBx #K911448 Triton Technology 04/16/1991 FB Series Biopsy Forceps #K955065 Olympus Optical Co., 01/24/1996 D. Description of the Device This… | 1991 |
| * | K955065 | Olympus FB Series Biopsy ForcepsSummary page 5…s: _ 7 4 Rog > Model - Device Description & Manufacturer 510(k)#/ Date Cleared Multiple Biopsy Device MBx #K911448 Triton Technology 04/16/1991 FB Series Biopsy Forceps #K955065 Olympus Optical Co., 01/24/1996 D. Description of the Device This instrument has been designed to be used with an Olympus endosc… | 1996 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All OCZ devicesOCZ Endoscopic Grasping/Cutting Instrument, Non-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OCZ
Too few OCZ 510(k)s in any year since 2007 to give a median.
Recalls per year · OCZ
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCZ
34in 2025
MAUDE reports naming product code OCZ, 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 | 1 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 242 |
| 2016 | 1 | — | 0 | 759 |
| 2017 | 0 | — | 0 | 734 |
| 2018 | 0 | — | 0 | 252 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 21 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 17 | 33 |
| 2023 | 0 | — | 0 | 25 |
| 2024 | 1 | — | 0 | 37 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Olympus BIOPSY FORCEPS has been designed to be used with an Olympus endoscope to
collect tissue samples within the upper and lower digestive tract and to extract the tissue
samples though the biopsy forceps with suction.
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/K012074 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012074: XBO1-824-18/19/20 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/K012074
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026