510(k) · Cleared
ClearedHX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Optical, Co. · PKL Hemostatic Metal Clip For The Gi Tract
Cleared on Mar 26, 1999 as substantially equivalent to K963160 (Olympus America, Inc., 1997) after a 25-day review. Its family tree reaches back 1 generation to 1997. 57 later devices descend from it.
- Decided
- Mar 26, 1999
- Review
- 25 days
- Class
- Class II
- Product code
- PKL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963160 (1997). 57 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- This deviceK990687 HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsOlympus Optical, Co. · 1999
- Descendant · cites it directly · 53 of its ownK013066 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 2001 · Recalled
- 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
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K013066HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 2001 · cites it directly53descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963160 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 1997 | — |
| 0 (this device) | K990687 | HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips | Olympus Optical, Co. | 1999 | — |
| +1 | K013066 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 2001 | 1 |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 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 PKL? 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 PKL device
- #1 K202333 Lockado Repositionable Hemostasis Clipscore 17.5 · 7 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 |
|---|---|---|---|
| * | K963160 | HX-5/6-1 Endoscopic Clipping DeviceSummary page 1…-459 Short Clip Common Name: Classification Name: Predicate Device: Endoscopic Clipping Device Endoscope and accessories Olympus HX-5/6-1 Endoscopic Clipping Device K963160 /( ?5 0 ££7 Vil e D. Description of the Device(s) The HX-5/6-1 Endoscopic Clipping Device is available as a set… | 1997 |
What descends from it? (57)
See all 573 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 PKL devicesPKL Hemostatic Metal Clip For The Gi Tract: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · PKL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PKL
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PKL
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PKL
1,170in 2025
MAUDE reports naming product code PKL, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 3 | 102 | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 3 | 143 | 0 | 34 |
| 2016 | 1 | — | 0 | 128 |
| 2017 | 2 | — | 0 | 398 |
| 2018 | 5 | 116 | 0 | 393 |
| 2019 | 4 | 231 | 1 | 699 |
| 2020 | 6 | 164 | 0 | 504 |
| 2021 | 2 | — | 0 | 668 |
| 2022 | 9 | 259 | 0 | 522 |
| 2023 | 2 | — | 0 | 863 |
| 2024 | 8 | 181 | 0 | 1,216 |
| 2025 | 6 | 162 | 0 | 1,170 |
| 2026 | 7 | 231 | 0 | — |
What is it indicated for?
Olympus HX-5/6-1 Endoscopic Clip Fixing Device has been designed for endoscopic clip placement within the gastrointestinal(GI) tract for the purpose of endoscopic marking, hemostasis in the upper GI tract for mucosal/submucosal defects <3cm, bleeding ulcers and arteries <2mm, polyps <1.5cm in diameter, and anchoring to affix jejunal feeding tubes to the wall of the small bowel. This device is not intended for the repair of GI tract lumenal perforations.
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/K990687 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990687: HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990687
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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