510(k) · Cleared
ClearedPatchassist Large
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polytouch Medical, Ltd. · ORQ Mesh, Surgical, Deployer
Cleared on Nov 23, 2010 as substantially equivalent to K101218 (Polytouch Medical, Ltd., 2010) after a 19-day review. Its family tree reaches back 1 generation to 2010. 3 later devices descend from it.
- Decided
- Nov 23, 2010
- Review
- 19 days
- Class
- Class II
- Product code
- ORQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K101218 (2010). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK101218 PatchassistPolytouch Medical, Ltd. · 2010
- This deviceK103269 Patchassist LargePolytouch Medical, Ltd. · 2010
- Descendant · cites it directly · 2 of its ownK121139 Accumesh Deployment SystemCovidien, LLC · 2012
- Descendant · cites it directly · 1 of its ownK123066 Accumesh Deployment SystemCovidien, LLC · 2012
- Descendant · cites it directly · 0 of its ownK130782 Accumesh Deployment SystemCovidien, LLC · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K101218 | Patchassist | Polytouch Medical, Ltd. | 2010 | — |
| 0 (this device) | K103269 | Patchassist Large | Polytouch Medical, Ltd. | 2010 | — |
| +1 | K121139 | Accumesh Deployment System | Covidien, LLC | 2012 | — |
| +1 | K123066 | Accumesh Deployment System | Covidien, LLC | 2012 | — |
| +1 | K130782 | Accumesh Deployment System | Covidien, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 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 ORQ? 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 ORQ device
- #1 K250395 BioBrace ® RC Delivery Systemscore 12.7 · 13 generations · no Class I recall
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 |
|---|---|---|---|
| * | K101218 | PatchassistSummary page 1…al and Plastic Surgery Devices 7.1.7 Predicate Devices: PolyTouch Medical Ltd. PatchAssistTm device cleared under K10 1218. 7.1.8 Device Description: Confidential… | 2010 |
What descends from it? (3)
3 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?
How does its category compare?
All ORQ devicesORQ Mesh, Surgical, Deployer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · ORQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ORQ
Too few ORQ 510(k)s in any year since 2007 to give a median.
Recalls per year · ORQ
No recall names ORQ since 2007.
Adverse event reports per year · ORQ
11in 2025
MAUDE reports naming product code ORQ, 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 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 11 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PatchAssistTm device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103269 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103269: Patchassist Large.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103269
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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