510(k) · Cleared
ClearedClearEndoclip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Finemedix Co., Ltd. · PKL Hemostatic Metal Clip For The Gi Tract
Cleared on Jun 28, 2019 as substantially equivalent to K123601 (Olympus Medical Systems Corp., 2013) after a 239-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.
- Decided
- Jun 28, 2019
- Review
- 239 days
- Class
- Class II
- Product code
- PKL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K963160 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- 3 generations backK990687 HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsOlympus Optical, Co. · 1999
- 2 generations backK013066 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 2001 · Recalled
- 1 generation backK123601 Single Use Repositionable ClipOlympus Medical Systems Corp. · 2013 · Recalled
- This deviceK183021 ClearEndoclipFinemedix Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK213338 Core-ClipIncore Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK200217 ClearEndoclipFinemedix Co., Ltd. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963160 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 1997 | — |
| −3 | K990687 | HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips | Olympus Optical, Co. | 1999 | — |
| −2 | K013066 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 2001 | 1 |
| −1 | K123601 | Single Use Repositionable Clip | Olympus Medical Systems Corp. | 2013 | 4 |
| 0 (this device) | K183021 | ClearEndoclip | Finemedix Co., Ltd. | 2019 | — |
| +1 | K213338 | Core-Clip | Incore Co., Ltd. | 2022 | — |
| +1 | K200217 | ClearEndoclip | Finemedix Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K123601 | Single Use Repositionable ClipSummary page 4…l clip for the GI tract), FHN (ligator, hemorrhoidal), MND (ligator, esophageal) Regulatory Class: II III. PREDICATE DEVICE Single Use Repositionable Clip (K123601), Manufacturer: Olympus Medical Systems Corp. This predicate has not been subject to a design-related recall. IV. DE… | 2013 |
| † | K013066 | HX-5/6-1 Endoscopic Clipping Device | 2001 |
What descends from it? (2)
2 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?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K213338 (Incore Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
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. 2019, this device’s year, is highlighted.
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?
ClearEndoclip is intended to be used with FDA-cleared endoscope for endoscopic clip placement within the gastrointestinal tract. It is indicated to be used for
(1) Endoscopic marking
(2) Hemostasis for
(a) Mucosal/sub-mucosal defects < 3cm
(b) Bleeding ulcers
(c)Arteries < 2 mm
(d)Polyps < 1.5 cm in diameter
(e)Diverticula in the colon
(3) Anchoring to affix jejunal feeding tubes to the wall of the small bowel
(4) As a supplementary method, closure of GI tract luminal perforations <20 mm that can be treated conservatively
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183021: ClearEndoclip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183021
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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