Tissue Regeneration Technologies, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Tissue Regeneration Technologies, LLC” (first 2006, latest 2021), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 104 days. Since 2017 the median was 106 days, against 136 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 86 |
| 2019 | 1 | 126 |
| 2020 | 1 | 143 |
| 2021 | 1 | 78 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tissue Regeneration Technologies, LLC took a median 106 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | 2 | 2 |
| PZL | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | 2 | 2 |
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | 1 | 1 |
Review panels
Most recent Tissue Regeneration Technologies, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210451 | OrthoGold 100 | ISA | 2021-05-05 | 78 |
| K200926 | OrthoGold 100 | PZL | 2020-08-28 | 143 |
| K191961 | OrthoGold | PZL | 2019-11-26 | 126 |
| K182682 | OrthoGold 100 | ISA | 2018-12-21 | 86 |
| K062081 | LITHOGOLD | LNS | 2006-11-02 | 104 |
Recalls
openFDA lists no recalls under a recalling firm named Tissue Regeneration Technologies, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Tissue Technologies, Inc. (9 510(k)s)
- Tissue Culture Innovations (6 510(k)s)
- Tissue Science Laboratories, Plc (6 510(k)s)
- Tissue Technologies Holdings, LLC (2 510(k)s)
- Tissue Culture Biologicals (1 510(k)s)
- Tissue Culture Biotec, Inc. (1 510(k)s)
- Tissue Differentiation Intelligence, LLC (1 510(k)s)
- Tissue Medical Lasers, Inc. (1 510(k)s)
- Tissue Regeneration Systems, Inc. (1 510(k)s)
- Tissue Regeneration Technologies, LLC Dba AS Softwave Trt (1 510(k)s)
- Tissue Regenix Group Plc (1 510(k)s)
- Tissue Repair Company (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tissue Regeneration Technologies, LLC?
FDA lists 5 510(k) clearances under the applicant name “Tissue Regeneration Technologies, LLC” (first 2006, latest 2021), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tissue Regeneration Technologies, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tissue Regeneration Technologies, LLC is 104 days. Since 2017: 106 days, versus 136 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Tissue Regeneration Technologies, LLC?
The most frequent FDA product codes under this applicant name are ISA (Massager, Therapeutic, Electric, 2); PZL (Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers, 2); LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological, 1).
Next steps
- See all 5 Tissue Regeneration Technologies, LLC clearances with predicates and recalls
- Run predicate analysis for product code ISA, Tissue Regeneration Technologies, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.