510(k) · Cleared
ClearedNeotract Anchor System Model TAS400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neotract, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Aug 4, 2010 as substantially equivalent to K101252 (Neotract, Inc., 2010) after a 16-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Aug 4, 2010
- Review
- 16 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K972679 (1997). 16 ancestors in all, the oldest K934738 (1994). No later device cites it as a predicate yet.
- Root · 7 generations backK972679 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1997
- 6 generations backK980022 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1998
- 5 generations backK994290 Bard Endoscopic Suturing SystemC.R. Bard, Inc. · 2000
- 4 generations backK062875 Endogastric Stomaphyx Device and AccessoriesEndogastric Solutions, Inc. · 2007
- 3 generations backK071651 Egs Serosafuse Implantable Fasteners, Associated Delivery Devices…Endogastric Solutions, Inc. · 2007
- 2 generations backK073644 Endogastric Solutions Stomaphyx Device and AccessoriesEndogastric Solutions, Inc. · 2008
- 1 generation backK101252 Neotract Anchor System Model: Ref 11208Neotract, Inc. · 2010
- This deviceK102028 Neotract Anchor System Model TAS400Neotract, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K972679 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −6 | K980022 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −5 | K994290 | Bard Endoscopic Suturing System | C.R. Bard, Inc. | 2000 | — |
| −4 | K062875 | Endogastric Stomaphyx Device and Accessories | Endogastric Solutions, Inc. | 2007 | — |
| −3 | K071651 | Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and… | Endogastric Solutions, Inc. | 2007 | — |
| −2 | K073644 | Endogastric Solutions Stomaphyx Device and Accessories | Endogastric Solutions, Inc. | 2008 | — |
| −1 | K101252 | Neotract Anchor System Model: Ref 11208 | Neotract, Inc. | 2010 | — |
| 0 (this device) | K102028 | Neotract Anchor System Model TAS400 | Neotract, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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 GAT? 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 GAT device
- #1 K230311 HyperSuturescore 20.2 · 7 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 |
|---|---|---|---|
| * | K101252 | Neotract Anchor System Model: Ref 11208Summary page 1…ntended for the approximation of tissue in open surgical procedures. Pr~edicate Devices NeoTract Anchor System K101252 Manufactured by NeoTract, Inc. Device Description The TAS400 NeoTract Anchor System is used for the approximation of soft tiss… | 2010 |
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 13 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 4 of the 16 ancestors have a recall of any class.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · GAT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAT
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAT
2,956in 2025
MAUDE reports naming product code GAT, 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 | 6 | 40 | 1 | 15 |
| 2008 | 4 | 93 | 0 | 15 |
| 2009 | 9 | 57 | 0 | 55 |
| 2010 | 11 | 27 | 3 | 79 |
| 2011 | 1 | — | 1 | 97 |
| 2012 | 6 | 61 | 0 | 253 |
| 2013 | 4 | 123 | 0 | 210 |
| 2014 | 4 | 45 | 0 | 165 |
| 2015 | 7 | 125 | 0 | 626 |
| 2016 | 10 | 139 | 0 | 688 |
| 2017 | 6 | 57 | 0 | 1,104 |
| 2018 | 6 | 95 | 0 | 1,453 |
| 2019 | 4 | 79 | 0 | 1,251 |
| 2020 | 5 | 201 | 0 | 1,220 |
| 2021 | 4 | 92 | 0 | 1,643 |
| 2022 | 5 | 109 | 0 | 1,419 |
| 2023 | 8 | 220 | 0 | 2,038 |
| 2024 | 3 | 140 | 0 | 2,597 |
| 2025 | 5 | 30 | 0 | 2,956 |
| 2026 | 5 | 83 | 0 | — |
What is it indicated for?
The NeoTract Anchor System is intended for the approximation of tissue in open surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102028: Neotract Anchor System Model TAS400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102028
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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