Threadstone, LLC: FDA clearances and approvals
Threadstone, LLC has 5 FDA 510(k) clearances (first 2023, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time: 140 days. Since 2017 its median was 140 days, against 108 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 1 | 294 |
| 2024 | 2 | 113 |
| 2025 | 1 | 244 |
| 2026 | 1 | 83 |
Review time against the same product codes
Since 2017, Threadstone, LLC's cleared 510(k)s took a median 140 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 5 | 5 |
Review panels
Most recent Threadstone, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254275 | HyperSuture All Green Extension Line | GAT | 2026-03-23 | 83 |
| K242201 | HyperSuture White/Green Extension Line | GAT | 2025-03-27 | 244 |
| K241376 | HyperSuture All Blue Extension Line | GAT | 2024-08-09 | 86 |
| K234079 | HyperSuture Extension Line | GAT | 2024-05-10 | 140 |
| K230311 | HyperSuture | GAT | 2023-11-24 | 294 |
Recalls
openFDA lists no recalls under a recalling firm named Threadstone, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Threadstone, LLC have?
Threadstone, LLC has 5 FDA 510(k) clearances (first 2023, latest 2026), across 1 product code in 1 review panel.
How long does FDA take to clear Threadstone, LLC's 510(k)s?
The median time from FDA receipt to decision across Threadstone, LLC's cleared 510(k)s is 140 days. Since 2017: 140 days, versus 108 days for all cleared 510(k)s in the same product codes.
What devices does Threadstone, LLC make?
Its most frequent FDA product codes are GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 5).
Has Threadstone, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Threadstone, LLC. Related entities may recall under other names.
Next steps
- See all 5 Threadstone, LLC clearances with predicates and recalls
- Run predicate analysis for product code GAT, Threadstone, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.