510(k) · Cleared
ClearedSingle Use Hemoclips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promisemed Hangzhou Meditech Co., Ltd. · PKL Hemostatic Metal Clip For The Gi Tract
Cleared on Jul 12, 2024 as substantially equivalent to K211787 (Hangzhou AGS MedTech Co., Ltd., 2022) after a 197-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- Jul 12, 2024
- Review
- 197 days
- Class
- Class II
- Product code
- PKL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K963160 (1997). No later device cites it as a predicate yet.
- Root · 9 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- 5 generations between
- 3 generations backK161463 SureClip (TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. · 2017
- 2 generations backK172727 HemoclipHangzhou AGS MedTech Co., Ltd. · 2018
- 1 generation backK211787 HemoclipHangzhou AGS MedTech Co., Ltd. · 2022
- This deviceK234124 Single Use HemoclipsPromisemed Hangzhou Meditech Co., Ltd. · 2024
Show all 9 generations
- Root · 9 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- 8 generations backK990687 HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsOlympus Optical, Co. · 1999
- 7 generations backK013066 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 2001 · Recalled
- 6 generations backK040148 Resolution Hemostasis Clipping DeviceBoston Scientific Corp · 2004 · Recalled
- 5 generations backK122660 Resolution Clip Model M00522600, M00522601, M00522602, M00522610…Boston Scientific Corporation · 2012
- 4 generations backK152001 Sterile Repositionable Hemostasis Clipping DeviceMicro-Tech (Nanjing) Co., Ltd. · 2015
- 3 generations backK161463 SureClip (TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. · 2017
- 2 generations backK172727 HemoclipHangzhou AGS MedTech Co., Ltd. · 2018
- 1 generation backK211787 HemoclipHangzhou AGS MedTech Co., Ltd. · 2022
- This deviceK234124 Single Use HemoclipsPromisemed Hangzhou Meditech Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K963160 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 1997 | — |
| −8 | K990687 | HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips | Olympus Optical, Co. | 1999 | — |
| −7 | K013066 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 2001 | 1 |
| −6 | K040148 | Resolution Hemostasis Clipping Device | Boston Scientific Corp | 2004 | 2 |
| −5 | K122660 | Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611… | Boston Scientific Corporation | 2012 | — |
| −4 | K152001 | Sterile Repositionable Hemostasis Clipping Device | Micro-Tech (Nanjing) Co., Ltd. | 2015 | — |
| −3 | K161463 | SureClip (TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 2017 | — |
| −2 | K172727 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2018 | — |
| −1 | K211787 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2022 | — |
| 0 (this device) | K234124 | Single Use Hemoclips | Promisemed Hangzhou Meditech Co., Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K211787 | HemoclipSummary page 4…Class II Product Code PKL 3. Legally Marketed Predicate Device [21 CFR 807.92 (a) (3)] Predicate Name Hemoclip 510(k) Number K211787 Product Code PKL Reference Devices No reference devices were used in this submission. 4. Device Descri… | 2022 |
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 27 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K211787.
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. 2024, 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 device is used for endoscopic clip placement within the gastrointestinal(GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3cm, bleeding ulcers, arteries less than 2mm, polyps less than 1.5cm in diameter and diverticula in the colon. Anchoring to affix jejunal feeding tubes to the wall of the small bowel. Closure of GI tract lumenal perforations less than 20mm that can be treated conservatively.
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/K234124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K234124: Single Use Hemoclips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K234124
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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