510(k) · Cleared
ClearedSingle Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short 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 Aug 1, 2019 as substantially equivalent to K142973 (Boston Scientific Corporation, 2014) after a 223-day review. Its family tree reaches back 6 generations to 1997. 2 later devices descend from it.
- Decided
- Aug 1, 2019
- Review
- 223 days
- Class
- Class II
- Product code
- PKL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K963160 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- 5 generations backK990687 HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsOlympus Optical, Co. · 1999
- 4 generations backK013066 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 2001 · Recalled
- 3 generations backK040148 Resolution Hemostasis Clipping DeviceBoston Scientific Corp · 2004 · Recalled
- 2 generations backK122660 Resolution Clip Model M00522600, M00522601, M00522602, M00522610…Boston Scientific Corporation · 2012
- 1 generation backK142973 Resolution ClipBoston Scientific Corporation · 2014
- This deviceK183590 Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip…Olympus Medical Systems Corp. · 2019
- Descendant · cites it directly · 1 of its ownK240617 Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip…Olympus Medical Systems Corp. · 2024
- Descendant · 2 generations on · 0 of its ownK260580 Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip…Olympus Medical Systems Corp. · 2026
Most influential descendants
Showing 2 of 2 · See all- K240617Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090…Olympus Medical Systems Corp. · 2024 · cites it directly1descendant
- K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090…Olympus Medical Systems Corp. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K963160 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 1997 | — |
| −5 | K990687 | HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips | Olympus Optical, Co. | 1999 | — |
| −4 | K013066 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 2001 | 1 |
| −3 | K040148 | Resolution Hemostasis Clipping Device | Boston Scientific Corp | 2004 | 2 |
| −2 | K122660 | Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611… | Boston Scientific Corporation | 2012 | — |
| −1 | K142973 | Resolution Clip | Boston Scientific Corporation | 2014 | — |
| 0 (this device) | K183590 | Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super… | Olympus Medical Systems Corp. | 2019 | — |
| +1 | K240617 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090… | Olympus Medical Systems Corp. | 2024 | — |
| +2 | K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090… | Olympus Medical Systems Corp. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K142973 | Resolution ClipSummary page 5…Device name Applicant 510(k) No. Resolution Clip Boston Scientific Corporation K142973 Reference device Device name Applicant 510(k) No. Endoscopic Cli… | 2014 |
| † | K013066 | HX-5/6-1 Endoscopic Clipping Device | 2001 |
| † | K123601 | Single Use Repositionable Clip | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240617 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090… | 2024 | 1 |
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 5 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K240617 (Olympus Medical Systems Corp., 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K142973.
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?
The Single Use Reloadable Clip Applicators and Clips have been designed to be used with an Olympus endoscope for endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of
(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) 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/K183590 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183590: Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183590
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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