510(k) · Cleared
ClearedMonotex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Riverpoint Medical · NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Cleared on Mar 26, 2014 as substantially equivalent to K072076 (Osteogenics Biomedical, Inc., 2007) after a 36-day review. Its family tree reaches back 1 generation to 2007. 8 later devices descend from it.
- Decided
- Mar 26, 2014
- Review
- 36 days
- Class
- Class II
- Product code
- NBY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K072076 (2007). 8 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK072076 Cytoplast Ptfe SutureOsteogenics Biomedical, Inc. · 2007
- This deviceK140415 MonotexRiverpoint Medical · 2014
- Descendant · cites it directly · 2 of its ownK173335 Gazelle PTFE and Suture Delivery DeviceDura Tap, LLC · 2018
- Descendant · cites it directly · 2 of its ownK160744 LOOK PTFE SutureSurgical Specialties Corporation · 2016
- Descendant · 2 generations on · 0 of its ownK233355 Cypris eXact Suturing SystemCypris Medical · 2024
- Descendant · 2 generations on · 0 of its ownK231277 TissueStatDurastat, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK192088 GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit Sutures · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K173335Gazelle PTFE and Suture Delivery DeviceDura Tap, LLC · 2018 · cites it directly2descendants
- K160744LOOK PTFE SutureSurgical Specialties Corporation · 2016 · cites it directly2descendants
- K233355Cypris eXact Suturing SystemCypris Medical · 2024 · 2 generations on0descendants
- K231277TissueStatDurastat, LLC · 2023 · 2 generations on0descendants
- K192088GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit Sutures · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K072076 | Cytoplast Ptfe Suture | Osteogenics Biomedical, Inc. | 2007 | — |
| 0 (this device) | K140415 | Monotex | Riverpoint Medical | 2014 | — |
| +1 | K173335 | Gazelle PTFE and Suture Delivery Device | Dura Tap, LLC | 2018 | — |
| +1 | K160744 | LOOK PTFE Suture | Surgical Specialties Corporation | 2016 | — |
| +2 | K233355 | Cypris eXact Suturing System | Cypris Medical | 2024 | — |
| +2 | K231277 | TissueStat | Durastat, LLC | 2023 | — |
| +2 | K192088 | GOLNIT Non-aborbable PTFE Surgical Suture | Antarma, LLC Dba Golnit Sutures | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K072076 | Cytoplast Ptfe SutureSummary page 1…NBY Classification Panel: Class 11(special controls); General and Plastic Surgery Predicate Devices (applicable 510(k) number listed): K(072076 (Cytoplast PTFIE Suture, Osteogenics Biomedical, Inc.) 510(k) Summary - PTFE Suture… | 2007 |
What descends from it? (8)
4 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?
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. 2014, 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?
MonoTex PTFE surgical suture is indicated for use In general soft tissue approximation and/or ligation, including cardiovascular, dental, general surgical procedures and repair of the duna mater. MonoTex PTFE sutures are not Indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues.
MonoTex PTFE suture is provided sterile as a single use device,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140415: Monotex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140415
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