510(k) · Cleared
ClearedOtsc (Over-the Scope-Clip) System Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ovesco Endoscopy AG · PKL Hemostatic Metal Clip For The Gi Tract
Cleared on Dec 1, 2010 as substantially equivalent to K020824 (Boston Scientific Corp, 2002) and 2 other predicates after a 194-day review. Its family tree reaches back 4 generations to 1997. 6 later devices descend from it.
- Decided
- Dec 1, 2010
- Review
- 194 days
- Class
- Class II
- Product code
- PKL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K963160 (1997). 6 ancestors in all. 6 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 deviceK101428 Otsc (Over-the Scope-Clip) System SetOvesco Endoscopy AG · 2010
- Descendant · cites it directly · 2 of its ownK120814 Padlock Clip-12Aponos Medical Corp. · 2012 · Recalled
- Descendant · cites it directly · 1 of its ownK241858 BARS Set (100.60)Ovesco Endoscopy AG · 2024
- Descendant · 2 generations on · 1 of its ownK180689 Padlock Clip defect closure device; Padlock Clip Pro-Select defect…STERIS Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK251562 OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG · 2025
- Descendant · cites it directly · 0 of its ownK220157 Disposable Hemostatic Closure Clip DeviceMicro-Tech (Nanjing) Co., Ltd. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K120814Padlock Clip-12Aponos Medical Corp. · 2012 · cites it directly2descendants
- K241858BARS Set (100.60)Ovesco Endoscopy AG · 2024 · cites it directly1descendant
- K180689Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure deviceSTERIS Corporation · 2018 · 2 generations on1descendant
- K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG · 2025 · 2 generations on0descendants
- K220157Disposable Hemostatic Closure Clip DeviceMicro-Tech (Nanjing) Co., Ltd. · 2022 · cites it directly0descendants
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) | K101428 | Otsc (Over-the Scope-Clip) System Set | Ovesco Endoscopy AG | 2010 | — |
| +1 | K120814 | Padlock Clip-12 | Aponos Medical Corp. | 2012 | 1 |
| +1 | K241858 | BARS Set (100.60) | Ovesco Endoscopy AG | 2024 | — |
| +2 | K180689 | Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure… | STERIS Corporation | 2018 | — |
| +2 | K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) | Ovesco Endoscopy AG | 2025 | — |
| +1 | K220157 | Disposable Hemostatic Closure Clip Device | Micro-Tech (Nanjing) Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K986669 | Speedband Multiple Ligator Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K020824 | Speedband Superview Super 7, Injection Speedband Superview Super 7, Models 4205 and 4238Summary page 1…Ligator, Hemorrhoidal Classification Name Ligator, Hemorrhoidal 876.4400; 876.1500, 876.5130 C. Predicate Devices: Trade Name Speedband Multiple Ligator (K98{669 and K020824) Trade Name Resolution Hemostasis Clipping Device (K040148) Trade Name InScope Multi-Clip Applier (K051950) K42… | 2002 |
| * | K040148 | Resolution Hemostasis Clipping DeviceSummary page 1…oidal 876.4400; 876.1500, 876.5130 C. Predicate Devices: Trade Name Speedband Multiple Ligator (K98{669 and K020824) Trade Name Resolution Hemostasis Clipping Device (K040148) Trade Name InScope Multi-Clip Applier (K051950) K428 . Lge 27 OTSC Over-The-Scope-Clipping System Set includin… | 2004 |
| * | K051950 | Inscope Multi-Clip Applier, Models IN22321, IN23321Summary page 1…Devices: Trade Name Speedband Multiple Ligator (K98{669 and K020824) Trade Name Resolution Hemostasis Clipping Device (K040148) Trade Name InScope Multi-Clip Applier (K051950) K428 . Lge 27 OTSC Over-The-Scope-Clipping System Set including the OTSC"™ Reloader Traditional Premarket Nolif… | 2005 |
What descends from it? (6)
3 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 13 years and passes through 4 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, K120814 (Aponos Medical Corp., 2012) has gone furthest, with 2 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. 2010, 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 OTSC system set is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for haemostasis or for treating lesions of the wall of gastrointestinal organs. Marking of lesions.
The OTSC clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:
- Endoscopic marking
- Hemostasis for:
- Mucosal/submucosal defects < 3 cm
- Bleeding ulcers
- Arteries < 2 mm
- Polyps < 1.5 cm in diameter
- Diverticula in the colon
- Closure of GI 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/K101428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101428: Otsc (Over-the Scope-Clip) System Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101428
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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