510(k) · Cleared
ClearedDemeTECH PTFE Nonabsorbable Surgical Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Demetech Corporation · NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Cleared on Oct 11, 2018 as substantially equivalent to K072076 (Osteogenics Biomedical, Inc., 2007) and 1 other predicate after a 118-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- Oct 11, 2018
- Review
- 118 days
- Class
- Class II
- Product code
- NBY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K072076 (2007). No later device cites it as a predicate yet.
- Root · 3 generations backK072076 Cytoplast Ptfe SutureOsteogenics Biomedical, Inc. · 2007
- 2 generations backK140415 MonotexRiverpoint Medical · 2014
- 1 generation backK160744 LOOK PTFE SutureSurgical Specialties Corporation · 2016
- This deviceK181578 DemeTECH PTFE Nonabsorbable Surgical SutureDemetech Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K072076 | Cytoplast Ptfe SutureSummary page 4…considered minor and do not raise questions concerning safety and effectiveness. Osteogenics Biomedical, Inc. Cytoplast PTFE Suture reference 510k number K072076 Surgical Specialties Corporation LOOK PTFE Suture reference 510k number K160744 E. Device Description:… | 2007 |
| * | K160744 | LOOK PTFE SutureSummary page 4…Osteogenics Biomedical, Inc. Cytoplast PTFE Suture reference 510k number K072076 Surgical Specialties Corporation LOOK PTFE Suture reference 510k number K160744 E. Device Description: DemeTECH PTFE Suture is a nonabsorbable, sterile surgical monofilament suture composed of… | 2016 |
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 11 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 3 ancestors has a recall.
- 6 other devices also cite its predicate K072076.
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. 2018, 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 DemeTECH PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery, and peripheral neural tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181578: DemeTECH PTFE Nonabsorbable Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181578
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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