Tactyl Technologies, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Tactyl Technologies, Inc.” (first 1990, latest 1996), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 140 days. 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 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 3 | 3 |
| HIS | Condom | 2 | 2 |
| FMC | Patient Examination Glove | 1 | 1 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
Review panels
Most recent Tactyl Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955464 | TACTYLON POWDER FREE EXAMINATION GLOVE | LZA | 1996-04-25 | 147 |
| K955419 | POWDER FREE TACTYLON SURGEONS GLOVE | KGO | 1996-04-15 | 140 |
| K953583 | LUBRICATED CONDOM | HIS | 1996-01-26 | 178 |
| K950185 | TACTYLON(TM) POWDER FREE SURGEONS GLOVE | KGO | 1995-04-13 | 86 |
| K911431 | TACTYLON(TM) CONDOM | HIS | 1994-12-27 | 1365 |
| K905109 | PATIENT EXAMINATION GLOVE/HYPOALLERGENIC | FMC | 1990-11-21 | 8 |
| K902831 | TACTYLON TM SURGICAL GLOVE | KGO | 1990-07-10 | 12 |
Recalls
openFDA lists no recalls under a recalling firm named Tactyl Technologies, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tactyl Technologies, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Tactyl Technologies, Inc.” (first 1990, latest 1996), across 4 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 Tactyl Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tactyl Technologies, Inc. is 140 days.
Which FDA product codes appear under Tactyl Technologies, Inc.?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 3); HIS (Condom, 2); FMC (Patient Examination Glove, 1).
Next steps
- See all 7 Tactyl Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KGO, Tactyl Technologies, Inc.'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.