Diversatek Healthcare: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Diversatek Healthcare” (first 2019, latest 2023), plus 1 De Novo decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 106 days. Since 2017 the median was 106 days, against 109 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 |
|---|---|---|
| 2019 | 1 | 241 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 60 |
| 2023 | 1 | 106 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Diversatek Healthcare 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 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QIS | Esophageal, Mucosal, Electrical Characterization | 2 | 1 |
| FFX | System, Gastrointestinal Motility (Electrical) | 1 | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 | 1 |
Review panels
Most recent Diversatek Healthcare 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230056 | MiVu Esophageal Endo Cap | QIS | 2023-04-25 | 106 |
| K222734 | Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing | OCX | 2022-11-08 | 60 |
| K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe | FFX | 2019-10-03 | 241 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180067 | De Novo | Esophageal, Mucosal, Electrical Characterization | 2019-12-23 |
Recalls
7 product recalls in 4 recall events; 7 initiated in the last five years. Most recent: 2026-03-18.
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 Diversatek Healthcare?
FDA lists 3 510(k) clearances under the applicant name “Diversatek Healthcare” (first 2019, latest 2023), plus 1 De Novo decision, across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Diversatek Healthcare?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diversatek Healthcare is 106 days. Since 2017: 106 days, versus 109 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Diversatek Healthcare?
The most frequent FDA product codes under this applicant name are QIS (Esophageal, Mucosal, Electrical Characterization, 2); FFX (System, Gastrointestinal Motility (Electrical), 1); OCX (Endoscopic Irrigation/Suction System, 1).
Next steps
- See all 3 Diversatek Healthcare clearances with predicates and recalls
- Run predicate analysis for product code QIS, Diversatek Healthcare'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.