510(k) · Cleared
ClearedDisposable Hemostasis Chip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical Inc./Cook Endoscopy · PKL Hemostatic Metal Clip For The Gi Tract
Cleared on Aug 31, 2012 as substantially equivalent to K023903 (Wilson-Cook Medical, Inc., 2003) after a 102-day review. Its family tree reaches back 3 generations to 1997. 3 later devices descend from it.
- Decided
- Aug 31, 2012
- Review
- 102 days
- Class
- Class II
- Product code
- PKL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K963160 (1997). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- 2 generations backK990687 HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsOlympus Optical, Co. · 1999
- 1 generation backK023903 Wilson-Cook Endoscopic Clipping DeviceWilson-Cook Medical, Inc. · 2003 · Recalled
- This deviceK121505 Disposable Hemostasis ChipWilson-Cook Medical Inc./Cook Endoscopy · 2012
- Descendant · cites it directly · 2 of its ownK132809 Instinct Endoscopic HemoclipWilson-Cook Medical, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK192697 Instinct Plus Endoscopic Clipping DeviceCook Endoscopy · 2020
- Descendant · 3 generations on · 0 of its ownK212323 Instinct Plus Endoscopic Clipping DeviceWilson-Cook Medical, Inc. · 2021 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K132809Instinct Endoscopic HemoclipWilson-Cook Medical, Inc. · 2013 · cites it directly2descendants
- K192697Instinct Plus Endoscopic Clipping DeviceCook Endoscopy · 2020 · 2 generations on1descendant
- K212323Instinct Plus Endoscopic Clipping DeviceWilson-Cook Medical, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963160 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 1997 | — |
| −2 | K990687 | HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips | Olympus Optical, Co. | 1999 | — |
| −1 | K023903 | Wilson-Cook Endoscopic Clipping Device | Wilson-Cook Medical, Inc. | 2003 | 1 |
| 0 (this device) | K121505 | Disposable Hemostasis Chip | Wilson-Cook Medical Inc./Cook Endoscopy | 2012 | — |
| +1 | K132809 | Instinct Endoscopic Hemoclip | Wilson-Cook Medical, Inc. | 2013 | — |
| +2 | K192697 | Instinct Plus Endoscopic Clipping Device | Cook Endoscopy | 2020 | — |
| +3 | K212323 | Instinct Plus Endoscopic Clipping Device | Wilson-Cook Medical, Inc. | 2021 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K023903 | Wilson-Cook Endoscopic Clipping DeviceSummary page 1…for the repair of GI tract lumenal perforations. The Disposable Hemostasis Clip has similar technological characteristics to the Wilson-Cook Endoscopic Clipping Device (K023903) in terms of general design and function but differs in terms of materials, dimensions, clip geometry and handle operation. Addit… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132809 | Instinct Endoscopic Hemoclip | 2013 | 2 |
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 15 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K132809 (Wilson-Cook Medical, Inc., 2013) 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. 2012, 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?
This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3 cm in the upper GI tract, bleeding ulcers, arteries less than 2 mm, and polyps less than 1.5 cm in diameter in the GI tract. This device is not intended for the repair of GI tract lumenal perforations.
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/K121505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121505: Disposable Hemostasis Chip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121505
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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