510(k) · Cleared
ClearedDisposable Hemoclip (AF series)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alton (Shanghai) Medical Instruments Co., Ltd. · PKL Hemostatic Metal Clip For The Gi Tract
Cleared on Jan 11, 2024 as substantially equivalent to K172727 (Hangzhou AGS MedTech Co., Ltd., 2018) after a 220-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Jan 11, 2024
- Review
- 220 days
- Class
- Class II
- Product code
- PKL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K963160 (1997). No later device cites it as a predicate yet.
- Root · 8 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- 7 generations backK990687 HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsOlympus Optical, Co. · 1999
- 6 generations backK013066 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 2001 · Recalled
- 5 generations backK040148 Resolution Hemostasis Clipping DeviceBoston Scientific Corp · 2004 · Recalled
- 4 generations backK122660 Resolution Clip Model M00522600, M00522601, M00522602, M00522610…Boston Scientific Corporation · 2012
- 3 generations backK152001 Sterile Repositionable Hemostasis Clipping DeviceMicro-Tech (Nanjing) Co., Ltd. · 2015
- 2 generations backK161463 SureClip (TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. · 2017
- 1 generation backK172727 HemoclipHangzhou AGS MedTech Co., Ltd. · 2018
- This deviceK231633 Disposable Hemoclip (AF series)Alton (Shanghai) Medical Instruments Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K963160 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 1997 | — |
| −7 | K990687 | HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips | Olympus Optical, Co. | 1999 | — |
| −6 | K013066 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 2001 | 1 |
| −5 | K040148 | Resolution Hemostasis Clipping Device | Boston Scientific Corp | 2004 | 2 |
| −4 | K122660 | Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611… | Boston Scientific Corporation | 2012 | — |
| −3 | K152001 | Sterile Repositionable Hemostasis Clipping Device | Micro-Tech (Nanjing) Co., Ltd. | 2015 | — |
| −2 | K161463 | SureClip (TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 2017 | — |
| −1 | K172727 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2018 | — |
| 0 (this device) | K231633 | Disposable Hemoclip (AF series) | Alton (Shanghai) Medical Instruments 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 |
|---|---|---|---|
| * | K172727 | HemoclipSummary page 5…number: 21CFR 876.4400 Regulation class: 2 Review Panel: Gastroenterology/Urology Product code: PKL III. Identification of Predicate device Predicate Submission Number: K172727 Trade/Device Name: Hemoclip Regulation Name: Hemorrhoidal Ligator Regulation Number: 21 CFR 876.4400 Regulatory Class: 2 Review P… | 2018 |
| † | K213338 | Core-Clip | 2022 |
| † | 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 27 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 5 other devices also cite its predicate K172727.
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 Disposable Hemoclip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:
1. Endoscopic marking
2. Hemostasis for:
* Mucosal/sub-mucosal defects < 3 cm
* Bleeding ulcers
* Arteries < 2 mm
* Polyps < 1.5 cm in diameter
* Diverticula in the colon
3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel;
4. As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231633 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231633: Disposable Hemoclip (AF series).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231633
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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