Branan Medical Corp.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Branan Medical Corp.” (first 2000, latest 2013), across 13 product codes in 1 review panel. Median 510(k) review time under this name: 116 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 | 1 | 527 |
| 2013 | 2 | 154 |
| 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 |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 5 | 5 |
| DJG | Enzyme Immunoassay, Opiates | 3 | 3 |
| DKZ | Enzyme Immunoassay, Amphetamine | 3 | 3 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 3 | 3 |
| DJC | Thin Layer Chromatography, Methamphetamine | 2 | 2 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 | 1 |
| DJJ | Fluorometry, Morphine | 1 | 1 |
| DJR | Enzyme Immunoassay, Methadone | 1 | 1 |
| DOE | Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. | 1 | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 | 1 |
Plus 3 more product codes.
Review panels
- Clinical Toxicology (24)
Most recent Branan Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122633 | TOXCUP DRUG SCREEN CUP | LDJ | 2013-02-07 | 162 |
| K122752 | FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD | JXN | 2013-01-30 | 145 |
| K103227 | ORATECT ORAL FLUID DRUG SCREEN DEVICES | DIO | 2012-04-11 | 527 |
| K082508 | FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD | DJG | 2008-11-21 | 84 |
| K040203 | MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 | DKZ | 2004-03-25 | 56 |
| K032057 | TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC | DIO | 2003-08-21 | 50 |
| K030113 | MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23 | DJG | 2003-07-02 | 170 |
| K023489 | QUICKTOX MULTIPLE DRUG DIPCARD | DIO | 2002-12-16 | 60 |
| K022355 | QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61 | DIO | 2002-07-30 | 11 |
| K013124 | MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP | DJJ | 2001-11-07 | 49 |
14 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2016-07-05.
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 Branan Medical Corp.?
FDA lists 24 510(k) clearances under the applicant name “Branan Medical Corp.” (first 2000, latest 2013), across 13 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 Branan Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Branan Medical Corp. is 116 days.
Which FDA product codes appear under Branan Medical Corp.?
The most frequent FDA product codes under this applicant name are DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 5); DJG (Enzyme Immunoassay, Opiates, 3); DKZ (Enzyme Immunoassay, Amphetamine, 3).
Next steps
- See all 24 Branan Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code DIO, Branan Medical 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, 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.