510(k) · Cleared
ClearedAFS Medical Sterile Single-Use Access Port System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Afs Medical Co., Ltd. · OTJ Laparoscopic Single Port Access Device
Cleared on Oct 14, 2021 as substantially equivalent to K090275 (Applied Medical Resources Corp., 2009) and 1 other predicate after a 394-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Oct 14, 2021
- Review
- 394 days
- Class
- Class II
- Product code
- OTJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K954824 (1996). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK954824 Protector Retractor & Protector Retractor with DrapeMedical Creative Technologies, Inc. · 1996
- 4 generations backK962147 Dexterity Pneumo Sleeve SetMedical Creative Technologies, Inc. · 1996
- 3 generations backK990414 Smith & Nephew Handport SystemSmith & Nephew, Inc. · 1999
- 2 generations backK014047 Applied Gelport Laparoscopic Hand Access DeviceApplied Medical Resources Corp. · 2002
- 1 generation backK090275 Gelport Single Incision Access SystemApplied Medical Resources Corp. · 2009
- This deviceK202688 AFS Medical Sterile Single-Use Access Port SystemAfs Medical Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954824 | Protector Retractor & Protector Retractor with Drape | Medical Creative Technologies, Inc. | 1996 | — |
| −4 | K962147 | Dexterity Pneumo Sleeve Set | Medical Creative Technologies, Inc. | 1996 | — |
| −3 | K990414 | Smith & Nephew Handport System | Smith & Nephew, Inc. | 1999 | — |
| −2 | K014047 | Applied Gelport Laparoscopic Hand Access Device | Applied Medical Resources Corp. | 2002 | — |
| −1 | K090275 | Gelport Single Incision Access System | Applied Medical Resources Corp. | 2009 | — |
| 0 (this device) | K202688 | AFS Medical Sterile Single-Use Access Port System | Afs Medical Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 OTJ? 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 OTJ device
- #1 K220081 Core-Sportscore 5.9 · 7 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K090275 | Gelport Single Incision Access SystemSummary page 5…ystem Product Code(s): OTJ Subsequent Product Code GCJ Regulation Number(s): 878.1500 Primary Predicate Devices: GelPort Single Incision Access System (K090275), Secondary Predicate: GelPort Laparoscopic Hand Access Device (K014047) Reference Device: SILS™ Port, Model… | 2009 |
| * | K014047 | Applied Gelport Laparoscopic Hand Access DeviceSummary page 5…(s): 878.1500 Primary Predicate Devices: GelPort Single Incision Access System (K090275), Secondary Predicate: GelPort Laparoscopic Hand Access Device (K014047) Reference Device: SILS™ Port, Model SILSPTT112A, K103253 Reference Device: OBP ONETRAC LX Illuminated Retr… | 2002 |
| † | K103253 | Sils Port | 2011 |
| † | K110792 | Gelpoint Path | 2011 |
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 25 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K090275.
How does its category compare?
All OTJ devicesOTJ Laparoscopic Single Port Access Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OTJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OTJ
130in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OTJ
No recall names OTJ since 2007.
Adverse event reports per year · OTJ
1in 2023
MAUDE reports naming product code OTJ, 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 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 3 | 130 | 0 | 12 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AFS MEDICAL’s Sterile Single-Use Access Port System for surgery is a manual device designed to access the peritoneal cavity during laparoscopic surgery minimally invasive surgery. Examples of procedures where the device may be used include colorectal, urological, and general surgery to access the surgical site
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202688: AFS Medical Sterile Single-Use Access Port System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202688
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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