Armour Pharmaceutical Co.: FDA clearances and approvals
Armour Pharmaceutical Co. has 7 FDA 510(k) clearances (first 1984, latest 1984), across 3 product codes in 2 review panels. Median 510(k) review time: 79 days.
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 |
|---|---|---|---|
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 5 | 5 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 | 1 |
| LDR | Controller, Infusion, Intravascular, Electronic | 1 | 1 |
Review panels
- Anesthesiology (6)
- General Hospital (1)
Most recent Armour Pharmaceutical Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K842209 | ARM-A-FLOW INTRAVENOUS FLOW REGULATOR | LDR | 1984-12-04 | 183 |
| K844005 | ARM-A-VIAL LV HEATER-BREATHING SYS | BZE | 1984-11-08 | 27 |
| K841991 | ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS | CCQ | 1984-07-27 | 79 |
| K841990 | ARM-A-CARE NEBULIZER-NEBULIZER | CCQ | 1984-07-27 | 79 |
| K841989 | ARM-A-VIAL LV SODIUM CHLORIDE INHALAT | CCQ | 1984-07-27 | 79 |
| K841988 | ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT | CCQ | 1984-07-27 | 79 |
| K841987 | ARM-A-VIAL LV STERIAL WATER FOR INHALA | CCQ | 1984-07-27 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Armour Pharmaceutical Co..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Armour Pharmaceutical Co. have?
Armour Pharmaceutical Co. has 7 FDA 510(k) clearances (first 1984, latest 1984), across 3 product codes in 2 review panels.
How long does FDA take to clear Armour Pharmaceutical Co.'s 510(k)s?
The median time from FDA receipt to decision across Armour Pharmaceutical Co.'s cleared 510(k)s is 79 days.
What devices does Armour Pharmaceutical Co. make?
Its most frequent FDA product codes are CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer), 5); BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer, 1); LDR (Controller, Infusion, Intravascular, Electronic, 1).
Has Armour Pharmaceutical Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Armour Pharmaceutical Co. Related entities may recall under other names.
Next steps
- See all 7 Armour Pharmaceutical Co. clearances with predicates and recalls
- Run predicate analysis for product code CCQ, Armour Pharmaceutical Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.