510(k) · Cleared
Recalled · Class II · 2023HX-5/6-1 Endoscopic Clipping Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · MND Ligator, Esophageal
Cleared on Dec 11, 2001 as substantially equivalent to K963160 (Olympus America, Inc., 1997) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1997. 53 later devices descend from it. It has been recalled once.
- Decided
- Dec 11, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- MND
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K963160 (1997). 53 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- 1 generation backK990687 HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsOlympus Optical, Co. · 1999
- This deviceK013066 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 2001
- Descendant · cites it directly · 48 of its ownK040148 Resolution Hemostasis Clipping DeviceBoston Scientific Corp · 2004 · Recalled
- Descendant · 2 generations on · 39 of its ownK122660 Resolution Clip Model M00522600, M00522601, M00522602, M00522610…Boston Scientific Corporation · 2012
- Descendant · 3 generations on · 23 of its ownK142973 Resolution ClipBoston Scientific Corporation · 2014
- Descendant · 4 generations on · 19 of its ownK151802 Resolution ClipBoston Scientific Corporation · 2015
- Descendant · 3 generations on · 15 of its ownK152001 Sterile Repositionable Hemostasis Clipping DeviceMicro-Tech (Nanjing) Co., Ltd. · 2015
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K040148Resolution Hemostasis Clipping DeviceBoston Scientific Corp · 2004 · cites it directly48descendants
- K122660Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611, M00522612Boston Scientific Corporation · 2012 · 2 generations on39descendants
- K142973Resolution ClipBoston Scientific Corporation · 2014 · 3 generations on23descendants
- K151802Resolution ClipBoston Scientific Corporation · 2015 · 4 generations on19descendants
- K152001Sterile Repositionable Hemostasis Clipping DeviceMicro-Tech (Nanjing) Co., Ltd. · 2015 · 3 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963160 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 1997 | — |
| −1 | K990687 | HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips | Olympus Optical, Co. | 1999 | — |
| 0 (this device) | K013066 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 2001 | — |
| +1 | K040148 | Resolution Hemostasis Clipping Device | Boston Scientific Corp | 2004 | 2 |
| +2 | K122660 | Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611… | Boston Scientific Corporation | 2012 | — |
| +3 | K142973 | Resolution Clip | Boston Scientific Corporation | 2014 | — |
| +4 | K151802 | Resolution Clip | Boston Scientific Corporation | 2015 | — |
| +3 | K152001 | Sterile Repositionable Hemostasis Clipping Device | Micro-Tech (Nanjing) Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 9 | 0 |
| 2023 | 2 | 0 |
| 2024 | 7 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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 MND? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K963160 | HX-5/6-1 Endoscopic Clipping DeviceSummary page 4…Device Classification Name : Endoscope and accessories Class :Class I Classification Number: 21CFR 876.1500 Predicate Device : HX-5/6-1 Endoscopic Clipping Device #K963160 Olympus HX-5/6 Endoscopic Clipping Device #K990687 | 'SSIWIANOATS 10 K)oes ) 1OAITB PNOC jer) uBsap 10 Yerragem ‘… | 1997 |
| * | K990687 | HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsSummary page 4…ories Class :Class I Classification Number: 21CFR 876.1500 Predicate Device : HX-5/6-1 Endoscopic Clipping Device #K963160 Olympus HX-5/6 Endoscopic Clipping Device #K990687 | 'SSIWIANOATS 10 K)oes ) 1OAITB PNOC jer) uBsap 10 Yerragem ‘woperado 30 POTIouT ‘95N PIPEONN uf s3Bmerno Jreogy… | 1999 |
What descends from it? (53)
See all 532 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 23, 2023 | Class II | Z-1418-2023 | Process change control | There have been complaints that the clip did not come out of the tube sheath during the procedure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K040148 (Boston Scientific Corp, 2004) has gone furthest, with 48 descendants of its own.
- 3 other devices also cite its predicate K963160.
How does its category compare?
All MND devicesMND Ligator, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MND
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · MND
Too few MND 510(k)s in any year since 2007 to give a median.
Recalls per year · MND
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MND
1,083in 2025
MAUDE reports naming product code MND, 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 | 84 |
| 2008 | 1 | — | 0 | 451 |
| 2009 | 1 | — | 0 | 1,161 |
| 2010 | 0 | — | 1 | 600 |
| 2011 | 0 | — | 1 | 672 |
| 2012 | 0 | — | 0 | 719 |
| 2013 | 1 | — | 0 | 750 |
| 2014 | 0 | — | 0 | 117 |
| 2015 | 0 | — | 0 | 76 |
| 2016 | 0 | — | 0 | 94 |
| 2017 | 0 | — | 0 | 88 |
| 2018 | 0 | — | 0 | 124 |
| 2019 | 0 | — | 0 | 294 |
| 2020 | 0 | — | 1 | 345 |
| 2021 | 0 | — | 0 | 674 |
| 2022 | 0 | — | 0 | 808 |
| 2023 | 0 | — | 0 | 689 |
| 2024 | 0 | — | 0 | 921 |
| 2025 | 0 | — | 1 (1) | 1,083 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Olympus HX-5/6-1 Rotatable Clip Fixing Devices are designed to be used for the following indications:
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/K013066 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013066: HX-5/6-1 Endoscopic Clipping Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013066
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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