510(k) · Cleared
ClearedLockado Repositionable Hemostasis Clip
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 Jan 14, 2021 as substantially equivalent to K151802 (Boston Scientific Corporation, 2015) after a 150-day review. Its family tree reaches back 7 generations to 1997. 7 later devices descend from it.
- Decided
- Jan 14, 2021
- Review
- 150 days
- Class
- Class II
- Product code
- PKL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K963160 (1997). 7 later devices descend from it, 5 citing it directly.
- 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 backK122660 Resolution Clip Model M00522600, M00522601, M00522602, M00522610…Boston Scientific Corporation · 2012
- 2 generations backK142973 Resolution ClipBoston Scientific Corporation · 2014
- 1 generation backK151802 Resolution ClipBoston Scientific Corporation · 2015
- This deviceK202333 Lockado Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK212748 Disposable Dual Action Tissue ClipMicro-Tech (Nanjing) Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK233772 Disposable Dual Action Tissue Closure DeviceMirco-Tech (Nanjing) Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK254069 Hemoclip (511 series, 543 series)Hangzhou AGS MedTech Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK252270 HemoclipHangzhou AGS MedTech Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK250229 Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K212748Disposable Dual Action Tissue ClipMicro-Tech (Nanjing) Co., Ltd. · 2022 · cites it directly2descendants
- K233772Disposable Dual Action Tissue Closure DeviceMirco-Tech (Nanjing) Co., Ltd. · 2024 · 2 generations on1descendant
- K254069Hemoclip (511 series, 543 series)Hangzhou AGS MedTech Co., Ltd. · 2026 · cites it directly0descendants
- K252270HemoclipHangzhou AGS MedTech Co., Ltd. · 2026 · cites it directly0descendants
- K250229Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd. · 2025 · 3 generations on0descendants
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 | K122660 | Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611… | Boston Scientific Corporation | 2012 | — |
| −2 | K142973 | Resolution Clip | Boston Scientific Corporation | 2014 | — |
| −1 | K151802 | Resolution Clip | Boston Scientific Corporation | 2015 | — |
| 0 (this device) | K202333 | Lockado Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 2021 | — |
| +1 | K212748 | Disposable Dual Action Tissue Clip | Micro-Tech (Nanjing) Co., Ltd. | 2022 | — |
| +2 | K233772 | Disposable Dual Action Tissue Closure Device | Mirco-Tech (Nanjing) Co., Ltd. | 2024 | — |
| +1 | K254069 | Hemoclip (511 series, 543 series) | Hangzhou AGS MedTech Co., Ltd. | 2026 | — |
| +1 | K252270 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2026 | — |
| +3 | K250229 | Dual Action Tissue Closure Device | Micro-Tech (Nanjing) Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 K254069 Hemoclip (511 series, 543 series)score 13.9 · 8 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 |
|---|---|---|---|
| * | K151802 | Resolution ClipSummary page 5…SureClipTM Repositionable Hemostasis Clip Manufacturer: Micro-Tech (Nanjing) Co., Ltd. 5. Identification of Predicate Device Predicate Device 510(k) Number: K151802 Product Name: Resolution 360™ Clip Manufacturer: Boston Scientific Corporation 6. Indications for Use The Lockado™ Re… | 2015 |
| † | K182556 | SureClip Repositionable Hemostasis Clip | 2018 |
What descends from it? (7)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K212748 (Micro-Tech (Nanjing) Co., Ltd., 2022) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K151802.
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. 2021, 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 Lockado™ Repositionable Hemostasis Clip is indicated for Endoscopic clip placement within the Gastrointestinal
tract in adult populations only via a straight or side viewing flexible endoscope for the purpose of :
(1) Endoscopic marking;
(2) Hemostasis for
(a) Mucosal / sub-mucosal defects < 3cm,
(b) Bleeding ulcers,
(c) polyps < 1.5cm in diameter,
(d) diverticula in the colon,
(e) Arteries <2 mm,’
(f) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection.
(3) as a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively.
(4) Anchoring to affix jejunal feeding tubes to the wall of the small bowel;
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/K202333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202333: Lockado Repositionable Hemostasis Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202333
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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