510(k) · Cleared
ClearedResolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · PKL Hemostatic Metal Clip For The Gi Tract
Cleared on Dec 3, 2012 as substantially equivalent to K040148 (Boston Scientific Corp, 2004) after a 94-day review. Its family tree reaches back 4 generations to 1997. 39 later devices descend from it.
- Decided
- Dec 3, 2012
- Review
- 94 days
- Class
- Class II
- Product code
- PKL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K963160 (1997). 39 later devices descend from it, 3 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 backK040148 Resolution Hemostasis Clipping DeviceBoston Scientific Corp · 2004 · Recalled
- This deviceK122660 Resolution Clip Model M00522600, M00522601, M00522602, M00522610…Boston Scientific Corporation · 2012
- Descendant · cites it directly · 23 of its ownK142973 Resolution ClipBoston Scientific Corporation · 2014
- Descendant · 2 generations on · 19 of its ownK151802 Resolution ClipBoston Scientific Corporation · 2015
- Descendant · cites it directly · 15 of its ownK152001 Sterile Repositionable Hemostasis Clipping DeviceMicro-Tech (Nanjing) Co., Ltd. · 2015
- Descendant · 2 generations on · 13 of its ownK161463 SureClip (TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. · 2017
- Descendant · cites it directly · 8 of its ownK172727 HemoclipHangzhou AGS MedTech Co., Ltd. · 2018
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K142973Resolution ClipBoston Scientific Corporation · 2014 · cites it directly23descendants
- K151802Resolution ClipBoston Scientific Corporation · 2015 · 2 generations on19descendants
- K152001Sterile Repositionable Hemostasis Clipping DeviceMicro-Tech (Nanjing) Co., Ltd. · 2015 · cites it directly15descendants
- K161463SureClip (TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. · 2017 · 2 generations on13descendants
- K172727HemoclipHangzhou AGS MedTech Co., Ltd. · 2018 · cites it directly8descendants
View 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 | K040148 | Resolution Hemostasis Clipping Device | Boston Scientific Corp | 2004 | 2 |
| 0 (this device) | K122660 | Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611… | Boston Scientific Corporation | 2012 | — |
| +1 | K142973 | Resolution Clip | Boston Scientific Corporation | 2014 | — |
| +2 | K151802 | Resolution Clip | Boston Scientific Corporation | 2015 | — |
| +1 | K152001 | Sterile Repositionable Hemostasis Clipping Device | Micro-Tech (Nanjing) Co., Ltd. | 2015 | — |
| +2 | K161463 | SureClip (TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 2017 | — |
| +1 | K172727 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 7 | 0 |
| 2023 | 2 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 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 |
|---|---|---|---|
| * | K040148 | Resolution Hemostasis Clipping DeviceSummary page 1…tion Number: 876.4400 Product Code: FHN and MND Classification: Class Il 3. Predicate Devices The Boston Scientific Corporation, Resolution™ Hemostasis Clipping Device (K040148). 4. Device Description The Resolution™ Hemostasis Clipping Device is a sterile, single-use, endoscopic clipping device consisti… | 2004 |
What descends from it? (39)
See all 393 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 15 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K142973 (Boston Scientific Corporation, 2014) has gone furthest, with 23 descendants of its own.
- 2 other devices also cite its predicate K040148.
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. 2012, 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 Resolution™ Hemostasis Clipping Device is indicated for use endoscopic clip placement within the gastrointestinal tract for the purpose of:
1. Endoscopic Marking
2. Hemostasis for;
Mucosal/sub-mucosal defects < 3cm
Bleeding ulcers
Arteries < 2cm
Polyps <1.5cm in diameter
o Diverticula in the colon
3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel
4. As a supplemental closure method of luminal perforations <20mm 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/K122660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122660: Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611, M00522612.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122660
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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