510(k) · Cleared
ClearedPatchassist
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 Jun 17, 2010 after a 48-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Jun 17, 2010
- Review
- 48 days
- Class
- Class II
- Product code
- ORQ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK101218 PatchassistPolytouch Medical, Ltd. · 2010
- Descendant · cites it directly · 3 of its ownK103269 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 4 of 4 · See all- K103269Patchassist LargePolytouch Medical, Ltd. · 2010 · cites it directly3descendants
- K121139Accumesh Deployment SystemCovidien, LLC · 2012 · cites it directly2descendants
- K123066Accumesh Deployment SystemCovidien, LLC · 2012 · cites it directly1descendant
- K130782Accumesh Deployment SystemCovidien, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K101218 | Patchassist | Polytouch Medical, Ltd. | 2010 | — |
| +1 | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (4)
4 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?
- Of its descendants, K103269 (Polytouch Medical, Ltd., 2010) has gone furthest, with 3 descendants of its own.
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 PatchAssist 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/K101218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101218: Patchassist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101218
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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