510(k) · Cleared
ClearedPadlock Clip defect closure device; Padlock Clip Pro-Select defect closure device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · PKL Hemostatic Metal Clip For The Gi Tract
Cleared on Apr 12, 2018 as substantially equivalent to K120814 (Aponos Medical Corp., 2012) after a 28-day review. Its family tree reaches back 6 generations to 1997. 1 later device descends from it.
- Decided
- Apr 12, 2018
- Review
- 28 days
- Class
- Class II
- Product code
- PKL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K963160 (1997). 8 ancestors in all. 1 later device descends 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 backK101428 Otsc (Over-the Scope-Clip) System SetOvesco Endoscopy AG · 2010
- 1 generation backK120814 Padlock Clip-12Aponos Medical Corp. · 2012 · Recalled
- This deviceK180689 Padlock Clip defect closure device; Padlock Clip Pro-Select defect…STERIS Corporation · 2018
- Descendant · cites it directly · 0 of its ownK192722 Padlock Clip defect closure system, Padlock Pro-Select defect…STERIS Corporation · 2019
Most influential descendants
Showing 1 of 1 · See all- K192722Padlock Clip defect closure system, Padlock Pro-Select defect closure deviceSTERIS Corporation · 2019 · cites it directly0descendants
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 | K101428 | Otsc (Over-the Scope-Clip) System Set | Ovesco Endoscopy AG | 2010 | — |
| −1 | K120814 | Padlock Clip-12 | Aponos Medical Corp. | 2012 | 1 |
| 0 (this device) | K180689 | Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure… | STERIS Corporation | 2018 | — |
| +1 | K192722 | Padlock Clip defect closure system, Padlock Pro-Select defect closure device | STERIS Corporation | 2019 | — |
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 |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K120814 | Padlock Clip-12Summary page 5…fication Name: Hemorrhoidal ligator Classification Number: 21 CFR 876.4400 Product Code: PKL 2. Predicate Device K120814 Aponos Medical, Padlock Clip 3. Description of Device The Padlock Clip™ ligation clip consists of a preloaded,… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192722 | Padlock Clip defect closure system, Padlock Pro-Select defect closure device | 2019 | 0 |
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 21 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K192722 (STERIS Corporation, 2019) has gone furthest, with 0 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. 2018, 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 Padlock Clip™ is indicated for use in flexible Endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.
The Padlock Clip™ is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:
* Endoscopic marking of lesions
* Hemostasis for:
o Mucosal/Submucosal defects
o Bleeding Ulcers
o Arteries <2mm
o Polyps <1.5cm in diameter
o Diverticula in the Colon
* Closure of GI tract 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/K180689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180689: Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180689
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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