510(k) · Cleared
ClearedKumar T-Anchors Hernia Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nashville Surgical Instruments · GAR Suture, Nonabsorbable, Synthetic, Polyamide
Cleared on Jul 15, 2008 as substantially equivalent to K963999 (United States Surgical, A Division of Tyco Healthc, 1996) after a 61-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Jul 15, 2008
- Review
- 61 days
- Class
- Class II
- Product code
- GAR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K944415 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK944415 Origin Tacker SystemOrigin Medsystems, Inc. · 1994
- 1 generation backK963999 Auto Suture* Modified Endoscopic Fascia Stapler** DeviceUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- This deviceK081366 Kumar T-Anchors Hernia SetNashville Surgical Instruments · 2008
- Descendant · cites it directly · 0 of its ownK173917 neoClose PDSNeosurgical, Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K173917neoClose PDSNeosurgical, Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 |
| 0 (this device) | K081366 | Kumar T-Anchors Hernia Set | Nashville Surgical Instruments | 2008 | — |
| +1 | K173917 | neoClose PDS | Neosurgical, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 GAR? 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 GAR device
- #1 K261484 Tissue Approximation Systemscore 11.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K963999 | Auto Suture* Modified Endoscopic Fascia Stapler** DeviceSummary page 4…(21 CFR 884.1720) Polyamide Suture (21 CFR 878.5020) Product Code GDW, KOG, GAR Predicate Devices 1. AutoSuture ProTack / AutoSuture Modified Endoscopic Fascia Stapler(K963999) 2. Ranfac Disposable Suture Grasper Needle (K032478) Device Description Kumar T-Anchors Hernia Set supplies 8 T-Anchors that ca… | 1996 |
| Kept off the family tree | K032478 | Ranfac Disposable Suture Grasper Needle Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4…Product Code GDW, KOG, GAR Predicate Devices 1. AutoSuture ProTack / AutoSuture Modified Endoscopic Fascia Stapler(K963999) 2. Ranfac Disposable Suture Grasper Needle (K032478) Device Description Kumar T-Anchors Hernia Set supplies 8 T-Anchors that carry size 0 polyamide suture. These are deployed in pa… |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173917 | neoClose PDS | 2018 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 11.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K173917 (Neosurgical, Ltd., 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K963999.
How does its category compare?
All GAR devicesGAR Suture, Nonabsorbable, Synthetic, Polyamide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GAR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GAR
Too few GAR 510(k)s in any year since 2007 to give a median.
Recalls per year · GAR
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAR
823in 2025
MAUDE reports naming product code GAR, 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 | 18 |
| 2008 | 1 | — | 1 | 14 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 39 |
| 2011 | 0 | — | 1 | 8 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 103 |
| 2015 | 1 | — | 0 | 86 |
| 2016 | 1 | — | 0 | 124 |
| 2017 | 1 | — | 0 | 180 |
| 2018 | 0 | — | 0 | 541 |
| 2019 | 0 | — | 0 | 518 |
| 2020 | 1 | — | 0 | 384 |
| 2021 | 1 | — | 0 | 532 |
| 2022 | 1 | — | 0 | 549 |
| 2023 | 1 | — | 1 | 607 |
| 2024 | 0 | — | 0 | 668 |
| 2025 | 0 | — | 0 | 823 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Kumar T-ANCHORS Hernia Set provides a means for fixation
of prosthetic material and passage of suture during repair of hernia
and soft tissue.
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/K081366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081366: Kumar T-Anchors Hernia Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081366
Report an extraction error
Are you the manufacturer?
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