510(k) · Cleared
ClearedPadlock Clip defect closure system, Padlock 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 Oct 24, 2019 as substantially equivalent to K180689 (STERIS Corporation, 2018) after a 27-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Oct 24, 2019
- Review
- 27 days
- Class
- Class II
- Product code
- PKL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K963160 (1997). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- 6 generations backK990687 HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsOlympus Optical, Co. · 1999
- 5 generations backK013066 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 2001 · Recalled
- 4 generations backK040148 Resolution Hemostasis Clipping DeviceBoston Scientific Corp · 2004 · Recalled
- 3 generations backK101428 Otsc (Over-the Scope-Clip) System SetOvesco Endoscopy AG · 2010
- 2 generations backK120814 Padlock Clip-12Aponos Medical Corp. · 2012 · Recalled
- 1 generation backK180689 Padlock Clip defect closure device; Padlock Clip Pro-Select defect…STERIS Corporation · 2018
- This deviceK192722 Padlock Clip defect closure system, Padlock Pro-Select defect…STERIS Corporation · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K963160 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 1997 | — |
| −6 | K990687 | HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips | Olympus Optical, Co. | 1999 | — |
| −5 | K013066 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 2001 | 1 |
| −4 | K040148 | Resolution Hemostasis Clipping Device | Boston Scientific Corp | 2004 | 2 |
| −3 | K101428 | Otsc (Over-the Scope-Clip) System Set | Ovesco Endoscopy AG | 2010 | — |
| −2 | K120814 | Padlock Clip-12 | Aponos Medical Corp. | 2012 | 1 |
| −1 | K180689 | Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure… | STERIS Corporation | 2018 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K180689 | Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure deviceSummary page 5…sification Name: Hemorrhoidal ligator Classification Number: 21 CFR 876.4400 Product Code: PKL 2. Predicate Device K180689 Padlock Clip defect closure device and Padlock Clip Pro-Select defect closure device Origina… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 9 ancestors have a recall of any class.
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 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 as stated in the FDA summary.
https://510kreport.com/device/K192722 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192722: Padlock Clip defect closure system, Padlock 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/K192722
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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