510(k) · Cleared
ClearedResolution 360™ ULTRA Clip
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 Sep 1, 2020 as substantially equivalent to K151802 (Boston Scientific Corporation, 2015) and 1 other predicate after a 266-day review. Its family tree reaches back 8 generations to 1997. 4 later devices descend from it.
- Decided
- Sep 1, 2020
- Review
- 266 days
- Class
- Class II
- Product code
- PKL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K963160 (1997). 4 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- 7 generations backK990687 HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsOlympus Optical, Co. · 1999
- 6 generations backK013066 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 2001 · Recalled
- 5 generations backK040148 Resolution Hemostasis Clipping DeviceBoston Scientific Corp · 2004 · Recalled
- 4 generations backK122660 Resolution Clip Model M00522600, M00522601, M00522602, M00522610…Boston Scientific Corporation · 2012
- 3 generations backK142973 Resolution ClipBoston Scientific Corporation · 2014
- 2 generations backK151802 Resolution ClipBoston Scientific Corporation · 2015
- 1 generation backK182556 SureClip Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. · 2018
- This deviceK193424 Resolution 360™ ULTRA ClipBoston Scientific Corporation · 2020
- Descendant · cites it directly · 2 of its ownK222503 Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA ClipBoston Scientific Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK253734 Taurus ClipTaurus Endoscopy · 2026
- Descendant · 2 generations on · 0 of its ownK250066 Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution…Boston Scientific Corporation · 2025
- Descendant · cites it directly · 0 of its ownK221124 MANTIS ClipBoston Scientific Corporation · 2022
Most influential descendants
Showing 4 of 4 · See all- K222503Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA ClipBoston Scientific Corporation · 2022 · cites it directly2descendants
- K253734Taurus ClipTaurus Endoscopy · 2026 · 2 generations on0descendants
- K250066Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602)…Boston Scientific Corporation · 2025 · 2 generations on0descendants
- K221124MANTIS ClipBoston Scientific Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K963160 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 1997 | — |
| −7 | K990687 | HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips | Olympus Optical, Co. | 1999 | — |
| −6 | K013066 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 2001 | 1 |
| −5 | K040148 | Resolution Hemostasis Clipping Device | Boston Scientific Corp | 2004 | 2 |
| −4 | K122660 | Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611… | Boston Scientific Corporation | 2012 | — |
| −3 | K142973 | Resolution Clip | Boston Scientific Corporation | 2014 | — |
| −2 | K151802 | Resolution Clip | Boston Scientific Corporation | 2015 | — |
| −1 | K182556 | SureClip Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 2018 | — |
| 0 (this device) | K193424 | Resolution 360™ ULTRA Clip | Boston Scientific Corporation | 2020 | — |
| +1 | K222503 | Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip | Boston Scientific Corporation | 2022 | — |
| +2 | K253734 | Taurus Clip | Taurus Endoscopy | 2026 | — |
| +2 | K250066 | Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip… | Boston Scientific Corporation | 2025 | — |
| +1 | K221124 | MANTIS Clip | Boston Scientific Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K151802 | Resolution ClipSummary page 4…ostatic Metal Clip for the GI Tract Regulation Name: Hemorrhoidal Ligator Regulation Number: 876.4400 Product Code: PKL Classification: Class II 510(k) Clearance Number: K151802 And Secondary Predicate Device: Trade Name: SureClip MAX Repositionable Hemostasis Clip Common Name: Hemostatic Metal Clip for… | 2015 |
| * | K182556 | SureClip Repositionable Hemostasis ClipSummary page 4…ostatic Metal Clip for the GI Tract Regulation Name: Hemorrhoidal Ligator Regulation Number: 876.4400 Product Code: PKL Classification: Class II 510(k) Clearance Number: K182556 K193424… | 2018 |
| † | K122660 | Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 | 2012 |
| † | K142973 | Resolution Clip | 2014 |
What descends from it? (4)
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 23 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K222503 (Boston Scientific Corporation, 2022) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K151802.
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. 2020, 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 360 ULTRA Clip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of:
1. Endoscopic marking
2. Hemostasis for:
-Mucosal/sub-mucosal defects <3cm
-Bleeding ulcers
-Arteries <2mm
-Polyps <1.5cm in diameter
-Diverticula in the colon
-Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection
3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel; and Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus
4. As a supplemental closure method of 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/K193424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193424: Resolution 360™ ULTRA Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193424
Report an extraction error
Are you the manufacturer?
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