510(k) · Cleared
ClearedOrigin Tacker System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Origin Medsystems, Inc. · OCW Endoscopic Tissue Approximation Device
Cleared on Nov 28, 1994 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 38 later devices descend from it.
- Decided
- Nov 28, 1994
- Review
- 81 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 0
38 later devices descend from it, 3 citing it directly.
- This deviceK944415 Origin Tacker SystemOrigin Medsystems, Inc. · 1994
- Descendant · cites it directly · 23 of its ownK963999 Auto Suture* Modified Endoscopic Fascia Stapler** DeviceUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- Descendant · cites it directly · 15 of its ownK032093 PariefixSofradim Production · 2003
- Descendant · 2 generations on · 14 of its ownK060494 Easytac Anchor. Easytac Delivery SystemMedchannel, LLC · 2006
- Descendant · 3 generations on · 13 of its ownK082396 Davol Absorbable Fastener System, Model (S) 0113080,0113081…C.R. Bard, Inc. · 2009
- Descendant · cites it directly · 12 of its ownK090470 Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien · 2009 · Recalled
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K963999Auto Suture* Modified Endoscopic Fascia Stapler** DeviceUnited States Surgical, A Division of Tyco Healthc · 1996 · cites it directly23descendants
- K032093PariefixSofradim Production · 2003 · cites it directly15descendants
- K060494Easytac Anchor. Easytac Delivery SystemMedchannel, LLC · 2006 · 2 generations on14descendants
- K082396Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086…C.R. Bard, Inc. · 2009 · 3 generations on13descendants
- K090470Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien · 2009 · cites it directly12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944415 | Origin Tacker System | Origin Medsystems, Inc. | 1994 | — |
| +1 | K963999 | Auto Suture* Modified Endoscopic Fascia Stapler** Device | United States Surgical, A Division of Tyco Healthc | 1996 | 1 |
| +1 | K032093 | Pariefix | Sofradim Production | 2003 | — |
| +2 | K060494 | Easytac Anchor. Easytac Delivery System | Medchannel, LLC | 2006 | — |
| +3 | K082396 | Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084… | C.R. Bard, Inc. | 2009 | — |
| +1 | K090470 | Autosuture Protack; Tacker System; Absorbatack Fixation Devices | Covidien | 2009 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OCW? 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 OCW device
- #1 K252400 Endomina EZFuse systemscore 12.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (38)
See all 383 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, K963999 (United States Surgical, A Division of Tyco Healthc, 1996) has gone furthest, with 23 descendants of its own.
How does its category compare?
All OCW devicesOCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCW
133in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCW
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCW
326in 2025
MAUDE reports naming product code OCW, 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 | 5 | 58 | 0 | 9 |
| 2008 | 4 | 70 | 0 | 47 |
| 2009 | 3 | 30 | 0 | 30 |
| 2010 | 4 | 91 | 0 | 10 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 28 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 2 | — | 0 | 74 |
| 2017 | 2 | — | 0 | 420 |
| 2018 | 2 | — | 0 | 413 |
| 2019 | 1 | — | 0 | 291 |
| 2020 | 1 | — | 0 | 183 |
| 2021 | 3 | 221 | 0 | 198 |
| 2022 | 0 | — | 0 | 235 |
| 2023 | 3 | 133 | 1 | 227 |
| 2024 | 0 | — | 0 | 211 |
| 2025 | 1 | — | 0 | 326 |
| 2026 | 2 | — | 3 | — |
https://510kreport.com/device/K944415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944415: Origin Tacker System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944415
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026