# PKL: Hemostatic Metal Clip For The Gi Tract

- Device class: 2; regulation: 21 CFR 876.4400; FDA's rule: 510(k) required
- FDA decisions: 67
- 510(k) review time 2021–2025: median 197 days (middle half 111–255)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 2
- 2018: 5
- 2019: 4
- 2020: 6
- 2021: 2
- 2022: 9
- 2023: 2
- 2024: 8
- 2025: 6
- 2026: 7

## Most-cited predicates
- K151802: Resolution Clip (2015), cited by 7
- K172727: Hemoclip (2018), cited by 6
- K202333: Lockado Repositionable Hemostasis Clip (2021), cited by 5
- K152001: Sterile Repositionable Hemostasis Clipping Device (2015), cited by 4
- K963160: HX-5/6-1 Endoscopic Clipping Device (1997), cited by 4
- K990687: HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips (1999), cited by 3
- K142973: Resolution Clip (2014), cited by 3
- K101428: Otsc (Over-the Scope-Clip) System Set (2010), cited by 3
- K122660: Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 (2012), cited by 3
- K161463: SureClip (TM) Repositionable Hemostasis Clip (2017), cited by 3

Source page: https://510kreport.com/product-code/PKL
Data by year (CSV): https://510kreport.com/product-code/PKL.csv