Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pm America, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
18 daysmedian FDA review time
57 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K830319 | AUTO PREP | Pm America, Inc. | 1983-03-29 | 57 | 0 |
| K820748 | POLI-MAK MODEL F-4 (FINAL | Pm America, Inc. | 1982-04-06 | 18 | 0 |
| K813102 | POLI-MAK II | Pm America, Inc. | 1981-11-24 | 21 | 0 |
| K812983 | DSD | Pm America, Inc. | 1981-11-10 | 15 | 0 |
| K801271 | MODEL 4900 OFF-LINE PREPARATION SYSTEM | Pm America, Inc. | 1980-06-09 | 12 | 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