Pharmaquest Corp.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Pharmaquest Corp.” (first 1981, latest 1995), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| FOH | Mattress, Water, Temperature Regulated | 4 | 4 |
| GYE | Encephalogram Telemetry System | 3 | 3 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 2 | 2 |
| CGA | Glucose Oxidase, Glucose | 2 | 2 |
| CBK | Ventilator, Continuous, Facility Use | 1 | 1 |
| FMA | Depressor, Tongue, Non-Surgical | 1 | 1 |
| MPG | Urinary Carbohydrate Analysis Kit | 1 | 1 |
Review panels
- General Hospital (5)
- Anesthesiology (3)
- Clinical Chemistry (3)
- Neurology (3)
Most recent Pharmaquest Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945519 | FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM | MPG | 1995-11-03 | 359 |
| K833880 | TELEPHONIC RECEIVER R-10 EEG | GYE | 1983-11-29 | 13 |
| K833236 | TELEPHONE TRANSMITTER T-10 EEG | GYE | 1983-11-29 | 105 |
| K830705 | MINI LANCET-BLOOD LANCET | FMA | 1983-04-08 | 32 |
| K822976 | HYPOCOUNT A | CGA | 1982-11-16 | 39 |
| K822486 | HOME BLOOD GLUCOSE MONITOR | CGA | 1982-11-05 | 80 |
| K820248 | RODDER VOLUME VENTILATOR | CBK | 1982-04-16 | 77 |
| K812850 | PTT-200 PULMONARY RECEIVER/MICROPROCES | BTY | 1981-12-03 | 55 |
| K812849 | PTT-200 TELEPHONIC PULMONARY TRANSMITT | BTY | 1981-12-03 | 55 |
| K813010 | EEG TELEPHONE TRANSMITTER, MODEL #T-7 | GYE | 1981-11-16 | 20 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pharmaquest Corp..
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 Pharmaquest Corp.?
FDA lists 14 510(k) clearances under the applicant name “Pharmaquest Corp.” (first 1981, latest 1995), across 7 product codes in 4 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 Pharmaquest Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pharmaquest Corp. is 36 days.
Which FDA product codes appear under Pharmaquest Corp.?
The most frequent FDA product codes under this applicant name are FOH (Mattress, Water, Temperature Regulated, 4); GYE (Encephalogram Telemetry System, 3); BTY (Calculator, Predicted Values, Pulmonary Function, 2).
Next steps
- See all 14 Pharmaquest Corp. clearances with predicates and recalls
- Run predicate analysis for product code FOH, Pharmaquest 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.