Delbio Incorporation: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Delbio Incorporation” (first 2011, latest 2014), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 204 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 | 3 | 264 |
| 2013 | 2 | 147 |
| 2014 | 1 | 151 |
| 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 |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 6 | 6 |
| DQA | Oximeter | 1 | 1 |
Review panels
- Clinical Chemistry (6)
- Anesthesiology (1)
Most recent Delbio Incorporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133090 | OXICARE FINGERTIP PULSE OXIMETER | DQA | 2014-02-28 | 151 |
| K132338 | DA01 BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2013-10-24 | 90 |
| K130244 | DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2013-08-23 | 204 |
| K120866 | DA01 BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2012-12-11 | 264 |
| K103329 | DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION | NBW | 2012-03-13 | 487 |
| K113343 | DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2012-02-08 | 86 |
| K100806 | DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM | NBW | 2011-09-16 | 543 |
Recalls
openFDA lists no recalls under a recalling firm named Delbio Incorporation.
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.
- Delbio Incorporated (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Delbio Incorporation?
FDA lists 7 510(k) clearances under the applicant name “Delbio Incorporation” (first 2011, latest 2014), across 2 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 Delbio Incorporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Delbio Incorporation is 204 days.
Which FDA product codes appear under Delbio Incorporation?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 6); DQA (Oximeter, 1).
Next steps
- See all 7 Delbio Incorporation clearances with predicates and recalls
- Run predicate analysis for product code NBW, Delbio Incorporation'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.