510(k) · Cleared
ClearedDual Action Tissue Closure Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Tech (Nanjing) Co., Ltd. · PKL Hemostatic Metal Clip For The Gi Tract
Cleared on Sep 8, 2025 as substantially equivalent to K233772 (Mirco-Tech (Nanjing) Co., Ltd., 2024) after a 224-day review. Its family tree reaches back 10 generations to 1997.
- Decided
- Sep 8, 2025
- Review
- 224 days
- Class
- Class II
- Product code
- PKL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K963160 (1997). No later device cites it as a predicate yet.
- Root · 10 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- 6 generations between
- 3 generations backK202333 Lockado Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. · 2021
- 2 generations backK212748 Disposable Dual Action Tissue ClipMicro-Tech (Nanjing) Co., Ltd. · 2022
- 1 generation backK233772 Disposable Dual Action Tissue Closure DeviceMirco-Tech (Nanjing) Co., Ltd. · 2024
- This deviceK250229 Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd. · 2025
Show all 10 generations
- Root · 10 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- 9 generations backK990687 HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsOlympus Optical, Co. · 1999
- 8 generations backK013066 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 2001 · Recalled
- 7 generations backK040148 Resolution Hemostasis Clipping DeviceBoston Scientific Corp · 2004 · Recalled
- 6 generations backK122660 Resolution Clip Model M00522600, M00522601, M00522602, M00522610…Boston Scientific Corporation · 2012
- 5 generations backK142973 Resolution ClipBoston Scientific Corporation · 2014
- 4 generations backK151802 Resolution ClipBoston Scientific Corporation · 2015
- 3 generations backK202333 Lockado Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. · 2021
- 2 generations backK212748 Disposable Dual Action Tissue ClipMicro-Tech (Nanjing) Co., Ltd. · 2022
- 1 generation backK233772 Disposable Dual Action Tissue Closure DeviceMirco-Tech (Nanjing) Co., Ltd. · 2024
- This deviceK250229 Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K963160 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 1997 | — |
| −9 | K990687 | HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips | Olympus Optical, Co. | 1999 | — |
| −8 | K013066 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 2001 | 1 |
| −7 | K040148 | Resolution Hemostasis Clipping Device | Boston Scientific Corp | 2004 | 2 |
| −6 | K122660 | Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611… | Boston Scientific Corporation | 2012 | — |
| −5 | K142973 | Resolution Clip | Boston Scientific Corporation | 2014 | — |
| −4 | K151802 | Resolution Clip | Boston Scientific Corporation | 2015 | — |
| −3 | K202333 | Lockado Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 2021 | — |
| −2 | K212748 | Disposable Dual Action Tissue Clip | Micro-Tech (Nanjing) Co., Ltd. | 2022 | — |
| −1 | K233772 | Disposable Dual Action Tissue Closure Device | Mirco-Tech (Nanjing) Co., Ltd. | 2024 | — |
| 0 (this device) | K250229 | Dual Action Tissue Closure Device | Micro-Tech (Nanjing) Co., Ltd. | 2025 | — |
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 |
|---|---|---|---|
| * | K233772 | Disposable Dual Action Tissue Closure DeviceSummary page 6…510(k) summary 4. Identification of Predicate/Reference Device Predicate Device: 510(k) Number: K233772 Product Name: Dual Action Tissue Closure Device Manufacturer: Micro-Tech (Nanjing) Co., Ltd. Reference Device: 510(k) Numbe… | 2024 |
| † | K202333 | Lockado Repositionable Hemostasis Clip | 2021 |
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 28 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 10 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. 2025, 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 Dual Action Tissue Closure Device is intended for use in flexible endoscopy for the compression of tissue in the gastrointestinal tract.
The Dual Action Tissue Closure Device is indicated for clip placement within the gastrointestinal tract for the purpose of:
Endoscopic marking,
Hemostasis for
Mucosal/sub-mucosal defects < 5 cm,
Bleeding ulcers,
Polyps < 1.5 cm in diameter,
Diverticula in the colon,
Arteries < 2 mm,
As a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250229: Dual Action Tissue 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/K250229
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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