510(k) · Cleared
ClearedReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · GDW Staple, Implantable
Cleared on Jul 17, 2015 as substantially equivalent to K140609 (Covidien, 2014) after a 28-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Jul 17, 2015
- Review
- 28 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K951658 (1995). 9 ancestors in all, the oldest K944415 (1994). No later device cites it as a predicate yet.
- Root · 6 generations backK951658 Lactosorb Pop RivetPoly-Medics,Inc. · 1995
- 5 generations backK961585 Surgical Dynamics Pop RivetUnited States Surgical, A Division of Tyco Healthc · 1996
- 4 generations backK071920 Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
- 3 generations backK090470 Autosuture Protack; Tacker System; Absorbatack Fixation DevicesCovidien · 2009 · Recalled
- 2 generations backK123109 Absorbatack 5MM Single Use Absorbable Fixation DeviceCovidien · 2012
- 1 generation backK140609 Reliatack Articulating Reloadable Fixation Device with Standard…Covidien · 2014
- This deviceK151659 ReliaTack Articulating Reloadable Fixation Device with Deep Purchase…Covidien, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K951658 | Lactosorb Pop Rivet | Poly-Medics,Inc. | 1995 | — |
| −5 | K961585 | Surgical Dynamics Pop Rivet | United States Surgical, A Division of Tyco Healthc | 1996 | — |
| −4 | K071920 | Autosuture Absorbable Tack and Applicator | United States Surgical, A Division of Tyco Healthc | 2007 | — |
| −3 | K090470 | Autosuture Protack; Tacker System; Absorbatack Fixation Devices | Covidien | 2009 | 2 |
| −2 | K123109 | Absorbatack 5MM Single Use Absorbable Fixation Device | Covidien | 2012 | — |
| −1 | K140609 | Reliatack Articulating Reloadable Fixation Device with Standard Purchase… | Covidien | 2014 | — |
| 0 (this device) | K151659 | ReliaTack Articulating Reloadable Fixation Device with Deep Purchase… | Covidien, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2007 | 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 GDW? 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 GDW device
- #1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.0 · 14 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 |
|---|---|---|---|
| * | K140609 | Reliatack Articulating Reloadable Fixation Device with Standard Purchase Absorble TacksSummary page 4…Stapler with Implantable Staples Classification Name: Staples, Implantable a. Pane! number and product code: 79 GDW b. Regulation number: 21 CFR 878.4750 510(k) Number: K140609 Manufacturer: Covidien Device Description: The ReliaTack™ Articulating Reloadable Fixation Device is a reloadable sterile, sing… | 2014 |
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 20 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 9 ancestors have a recall of any class.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · GDW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GDW
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GDW
3in 2025
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · GDW
11,905in 2025
MAUDE reports naming product code GDW, 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 | 8 | 56 | 9 | 2,401 |
| 2008 | 7 | 57 | 0 | 2,380 |
| 2009 | 13 | 27 | 22 | 4,014 |
| 2010 | 10 | 39 | 2 | 3,768 |
| 2011 | 11 | 49 | 9 | 3,826 |
| 2012 | 9 | 45 | 11 (1) | 3,717 |
| 2013 | 13 | 49 | 1 | 3,777 |
| 2014 | 15 | 63 | 0 | 4,784 |
| 2015 | 8 | 111 | 6 | 4,899 |
| 2016 | 11 | 96 | 2 | 5,106 |
| 2017 | 13 | 103 | 3 | 11,643 |
| 2018 | 7 | 90 | 3 | 14,914 |
| 2019 | 12 | 205 | 4 (4) | 16,600 |
| 2020 | 10 | 88 | 11 | 12,332 |
| 2021 | 9 | 233 | 0 | 13,015 |
| 2022 | 7 | 89 | 0 | 13,605 |
| 2023 | 4 | 267 | 1 | 14,623 |
| 2024 | 2 | — | 0 | 13,280 |
| 2025 | 3 | 111 | 3 | 11,905 |
| 2026 | 3 | 141 | 0 | — |
What is it indicated for?
The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151659: ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151659
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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