Biomedix, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Biomedix, Inc.” (first 1993, latest 2014), across 5 product codes in 5 review panels. Median 510(k) review time under this name: 90 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 | 30 |
| 2013 | 0 | — |
| 2014 | 1 | 28 |
| 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 3 | 3 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 3 | 3 |
| CGA | Glucose Oxidase, Glucose | 2 | 2 |
| JAF | Monitor, Ultrasonic, Nonfetal | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
Review panels
- Cardiovascular (3)
- General Hospital (3)
- Clinical Chemistry (2)
- Radiology (2)
- Anesthesiology (1)
Most recent Biomedix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142097 | SELEC-3 I.V.ADMINISTRATION SET | FPA | 2014-08-29 | 28 |
| K122281 | PADNET 2.0 | JOM | 2012-08-29 | 30 |
| K073146 | PADNET+ | JOM | 2007-11-21 | 13 |
| K050182 | Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM | CGA | 2005-08-09 | 194 |
| K042616 | BIOMEDIX PADNET LAB | JOM | 2004-10-12 | 19 |
| K033627 | Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM | CGA | 2004-05-21 | 184 |
| K973857 | FLOSTAT VASCULAR REPORT GENERATOR (VRG) | JAF | 1997-12-29 | 81 |
| K973644 | FLOSTAT VASCULAR LAB | JAF | 1997-12-23 | 90 |
| K961928 | BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102 | FPA | 1996-09-16 | 122 |
| K925645 | SELEC-3 | FPA | 1993-09-27 | 322 |
1 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-08-14.
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 Biomedix, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Biomedix, Inc.” (first 1993, latest 2014), across 5 product codes in 5 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 Biomedix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomedix, Inc. is 90 days.
Which FDA product codes appear under Biomedix, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 3); JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic, 3); CGA (Glucose Oxidase, Glucose, 2).
Next steps
- See all 11 Biomedix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Biomedix, 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.