Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Armstrong Ind., Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
133 daysmedian FDA review time
142 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K852181 | ELECTROCARDIOGRAPH | Armstrong Ind., Inc. | 1985-10-09 | 142 | 0 |
| K852281 | SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER | Armstrong Ind., Inc. | 1985-10-09 | 133 | 0 |
| K852282 | SCHILLER MINISCOPE MS-2 EKG SCOPE | Armstrong Ind., Inc. | 1985-10-09 | 133 | 0 |
| K851705 | LARYNGOSCOPE | Armstrong Ind., Inc. | 1985-05-21 | 26 | 0 |
| K822727 | RESCUER | Armstrong Ind., Inc. | 1982-09-28 | 20 | 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