Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Armour Pharmaceutical Co. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
183 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K842209 | ARM-A-FLOW INTRAVENOUS FLOW REGULATOR | Armour Pharmaceutical Co. | 1984-12-04 | 183 | 0 |
| K844005 | ARM-A-VIAL LV HEATER-BREATHING SYS | Armour Pharmaceutical Co. | 1984-11-08 | 27 | 0 |
| K841989 | ARM-A-VIAL LV SODIUM CHLORIDE INHALAT | Armour Pharmaceutical Co. | 1984-07-27 | 79 | 0 |
| K841991 | ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS | Armour Pharmaceutical Co. | 1984-07-27 | 79 | 0 |
| K841990 | ARM-A-CARE NEBULIZER-NEBULIZER | Armour Pharmaceutical Co. | 1984-07-27 | 79 | 0 |
| K841987 | ARM-A-VIAL LV STERIAL WATER FOR INHALA | Armour Pharmaceutical Co. | 1984-07-27 | 86 | 0 |
| K841988 | ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT | Armour Pharmaceutical Co. | 1984-07-27 | 79 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda