Demetech Corp.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under 2 spellings of the applicant name “Demetech Corp.” (first 2002, latest 2020), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 165 days. Since 2017 the median was 118 days, against 140 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 | 1 | 184 |
| 2014 | 2 | 343 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 96 |
| 2019 | 2 | 148 |
| 2020 | 1 | 50 |
| 2021 | 0 | — |
| 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 Demetech Corp. took a median 118 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 3 | 3 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 3 | 3 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | 2 |
| FXX | Mask, Surgical | 1 | 1 |
| GAL | Suture, Absorbable, Natural | 1 | 1 |
| GAP | Suture, Nonabsorbable, Silk | 1 | 1 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | 1 | 1 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 1 | 1 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 | 1 |
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 1 | 1 |
Review panels
Most recent Demetech Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201479 | DemeMASK | FXX | 2020-07-24 | 50 |
| K191361 | DemeDIOX Barbed Absorbable Surgical Suture | NEW | 2019-11-07 | 170 |
| K190777 | DemeTECH DemeFORCE Nonabsorbable Surgical Suture | GAT | 2019-07-31 | 127 |
| K181578 | DemeTECH PTFE Nonabsorbable Surgical Suture | NBY | 2018-10-11 | 118 |
| K181582 | DemeTECH DemeDIOX absorbable surgical suture | NEW | 2018-08-27 | 73 |
| K141007 | DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE | GAQ | 2014-09-25 | 160 |
| K123940 | DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE | GAM | 2014-05-30 | 526 |
| K130083 | DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE | GAM | 2013-07-17 | 184 |
| K082097 | DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE | NEW | 2010-01-08 | 533 |
| K072930 | DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT | GAL | 2008-04-30 | 197 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Demetech Corp..
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Demetech Corp. (10)
- Demetech Corporation (5)
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.
- Demetech AB (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Demetech Corp.?
FDA lists 15 510(k) clearances under 2 spellings of the applicant name “Demetech Corp.” (first 2002, latest 2020), across 10 product codes in 2 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 Demetech Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Demetech Corp. is 165 days. Since 2017: 118 days, versus 140 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Demetech Corp.?
The most frequent FDA product codes under this applicant name are GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 3); NEW (Suture, Surgical, Absorbable, Polydioxanone, 3); GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 2).
Next steps
- See all 15 Demetech Corp. clearances with predicates and recalls
- Run predicate analysis for product code GAM, Demetech Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.