510(k) · Cleared
Recalled · Class II · 2023Single Use Repositionable Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · PKL Hemostatic Metal Clip For The Gi Tract
Cleared on Apr 29, 2013 as substantially equivalent to K013066 (Olympus America, Inc., 2001) after a 159-day review. Its family tree reaches back 3 generations to 1997. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 29, 2013
- Review
- 159 days
- Class
- Class II
- Product code
- PKL
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 3 generations to K963160 (1997). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- 2 generations backK990687 HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsOlympus Optical, Co. · 1999
- 1 generation backK013066 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 2001 · Recalled
- This deviceK123601 Single Use Repositionable ClipOlympus Medical Systems Corp. · 2013
- Descendant · cites it directly · 2 of its ownK183021 ClearEndoclipFinemedix Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK213338 Core-ClipIncore Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK200217 ClearEndoclipFinemedix Co., Ltd. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963160 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 1997 | — |
| −2 | 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 |
| 0 (this device) | K123601 | Single Use Repositionable Clip | Olympus Medical Systems Corp. | 2013 | — |
| +1 | K183021 | ClearEndoclip | Finemedix Co., Ltd. | 2019 | — |
| +2 | K213338 | Core-Clip | Incore Co., Ltd. | 2022 | — |
| +2 | K200217 | ClearEndoclip | Finemedix Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K013066 | HX-5/6-1 Endoscopic Clipping DeviceSummary page 2…oscopic Clipping Device HX-5LR-1, HX-6UR-1 Standard Clip HX-600-135 ®m Common Name: Endoscopic Clipping Device ™ 'Manufacturen , Olympus Optical Co., Ltd. ® 510() No. K013066 4 Device Description This instrument is intended to be used with Olympus endoscope for endoscopic clip placement within the gas… | 2001 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183021 | ClearEndoclip | 2019 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 4, 2023 | Class II | Z-1990-2023 | Under Investigation by firm | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include… |
| May 4, 2023 | Class II | Z-1987-2023 | Under Investigation by firm | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include… |
| May 4, 2023 | Class II | Z-1988-2023 | Under Investigation by firm | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include… |
| May 4, 2023 | Class II | Z-1989-2023 | Under Investigation by firm | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K183021 (Finemedix Co., Ltd., 2019) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K013066.
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. 2013, 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?
This instrument is intended to be used with Olympus endoscope for endoscopic clip placement within the gastrointestinal (Gl) tract. It is indicated to be used for
(1) endoscopic marking
(2) hemostasis for
(a) mucosal/sub-mucosal defects < 3 cm,
(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 Gl tract luminal perforations < 20 mm that can be treated conservatively.
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/K123601 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123601: Single Use Repositionable Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123601
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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