Bio Clinic Co.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Bio Clinic Co.” (first 1988, latest 1993), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 48 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 |
|---|---|---|---|
| IOQ | Bed, Flotation Therapy, Powered | 4 | 4 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 3 | 3 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 2 | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
Review panels
Most recent Bio Clinic Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K930791 | AMERICAN POWER CONVERSIONS, BACK-UPS 600 | FMF | 1993-08-06 | 171 |
| K932480 | PRISM | IOQ | 1993-07-21 | 58 |
| K926189 | ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE | IOQ | 1993-06-24 | 198 |
| K921958 | ELISA TUBE TSH TEST | JLW | 1992-07-02 | 66 |
| K922140 | ORTHODERM CONVERTIBLE II | IOQ | 1992-05-27 | 21 |
| K921212 | MIRCO ELISA HPL TEST KIT | JHI | 1992-05-07 | 56 |
| K921211 | NOW PREGNANCY TEST KIT | JHI | 1992-05-07 | 56 |
| K920921 | ELISA TUBE PROLACTIN TEST KIT | CFT | 1992-04-08 | 40 |
| K920920 | ELISA TUBE LH TEST KIT | CEP | 1992-04-08 | 40 |
| K920918 | TMB CHROMOGEN/SUBSTRATE REAGENT SET | JHI | 1992-04-07 | 39 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bio Clinic Co..
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 Bio Clinic Co.?
FDA lists 14 510(k) clearances under the applicant name “Bio Clinic Co.” (first 1988, latest 1993), across 8 product codes in 3 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 Bio Clinic Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio Clinic Co. is 48 days.
Which FDA product codes appear under Bio Clinic Co.?
The most frequent FDA product codes under this applicant name are IOQ (Bed, Flotation Therapy, Powered, 4); JHI (Visual, Pregnancy Hcg, Prescription Use, 3); FNM (Mattress, Air Flotation, Alternating Pressure, 2).
Next steps
- See all 14 Bio Clinic Co. clearances with predicates and recalls
- Run predicate analysis for product code IOQ, Bio Clinic Co.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.