Dbt Medical , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Dbt Medical , Ltd.” (first 1985, latest 1985), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 65 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 |
|---|---|---|---|
| EXB | Collector, Ostomy | 3 | 3 |
| EXJ | Device, Incontinence, Urosheath Type, Sterile | 1 | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 | 1 |
Review panels
Most recent Dbt Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K851681 | SAFESTRETCH INCONTINENCE SYSTEM | KNX | 1985-06-28 | 66 |
| K851680 | OSTOMY BAGS ILEOSTOMY | EXB | 1985-06-27 | 65 |
| K851679 | OSTOMY BAGS COLOSTOMY | EXB | 1985-06-27 | 65 |
| K851678 | OSTOMY BAGS URETHEROSTOMY | EXB | 1985-06-27 | 65 |
| K851682 | SAFESEAL REUSABLE URINAL SYSTEM | EXJ | 1985-06-24 | 62 |
Recalls
openFDA lists no recalls under a recalling firm named Dbt Medical , Ltd..
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 Dbt Medical , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Dbt Medical , Ltd.” (first 1985, latest 1985), 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 Dbt Medical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dbt Medical , Ltd. is 65 days.
Which FDA product codes appear under Dbt Medical , Ltd.?
The most frequent FDA product codes under this applicant name are EXB (Collector, Ostomy, 3); EXJ (Device, Incontinence, Urosheath Type, Sterile, 1); KNX (Collector, Urine, (And Accessories) For Indwelling Catheter, 1).
Next steps
- See all 5 Dbt Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EXB, Dbt Medical , Ltd.'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.