510(k) · Cleared
ClearedStitchkit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Origami Surgical, LLC · NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Cleared on Sep 5, 2013 as substantially equivalent to K981531 (Lsi Solutions, 1998) after a 268-day review. Its family tree reaches back 2 generations to 1995. 6 later devices descend from it.
- Decided
- Sep 5, 2013
- Review
- 268 days
- Class
- Class II
- Product code
- NBY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954853 (1995). 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK954853 Auto Suture Suture ClosureUnited States Surgical, A Division of Tyco Healthc · 1995
- 1 generation backK981531 Suture Placement Device and AccessoriesLsi Solutions · 1998
- This deviceK123811 StitchkitOrigami Surgical, LLC · 2013
- Descendant · cites it directly · 3 of its ownK173874 StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC · 2018
- Descendant · 2 generations on · 2 of its ownK202950 StitchKit COMBOOrigami Surgical · 2021
- Descendant · 3 generations on · 1 of its ownK211792 StitchKitOrigami Surgical Inc . · 2021
- Descendant · 4 generations on · 0 of its ownK221527 StitchKitOrigami Surgical Inc . · 2023
- Descendant · cites it directly · 0 of its ownK191317 StitchKitOrigami Surgical · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K173874StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDOOrigami Surgical, LLC · 2018 · cites it directly3descendants
- K202950StitchKit COMBOOrigami Surgical · 2021 · 2 generations on2descendants
- K211792StitchKitOrigami Surgical Inc . · 2021 · 3 generations on1descendant
- K221527StitchKitOrigami Surgical Inc . · 2023 · 4 generations on0descendants
- K191317StitchKitOrigami Surgical · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954853 | Auto Suture Suture Closure | United States Surgical, A Division of Tyco Healthc | 1995 | — |
| −1 | K981531 | Suture Placement Device and Accessories | Lsi Solutions | 1998 | — |
| 0 (this device) | K123811 | Stitchkit | Origami Surgical, LLC | 2013 | — |
| +1 | K173874 | StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO | Origami Surgical, LLC | 2018 | — |
| +2 | K202950 | StitchKit COMBO | Origami Surgical | 2021 | — |
| +3 | K211792 | StitchKit | Origami Surgical Inc . | 2021 | — |
| +4 | K221527 | StitchKit | Origami Surgical Inc . | 2023 | — |
| +1 | K191317 | StitchKit | Origami Surgical | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 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 NBY? 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 NBY device
- #1 K231277 TissueStatscore 6.9 · 3 generations · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981531 | Suture Placement Device and AccessoriesSummary page 2…Page 2 Summary of Technological Characteristics vs. Predicate The predicates for the StitchKit® device are the LSI Solutions Suture Placement Device (K981531); and Gore-Texe Nonabsorbable ePTFE Surgical Suture (reference 21 CFR Part 878, Docket No. 94P-0347). The LSI Solutions Sutur… | 1998 |
| * | — | Gore-Tex Nonabsorbable ePTFE Surgical Suture Named without a submission number |
What descends from it? (6)
3 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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 15.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K173874 (Origami Surgical, LLC, 2018) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K981531.
How does its category compare?
All NBY devicesNBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NBY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NBY
58in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBY
No recall names NBY since 2007.
Adverse event reports per year · NBY
1in 2025
MAUDE reports naming product code NBY, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 161 | 0 | 0 |
| 2018 | 4 | 99 | 0 | 0 |
| 2019 | 3 | 58 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The StitchKit device facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The ePTFE suture contained within StltchKito is indicated for use in all types of soft tissue approximation, including use in cardiovascular surgery and dura mater repair. It is recommended for use where reduced suture line bleeding during cardiovascular anastamotic procedures is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123811: Stitchkit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123811
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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