Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ppg/Applied Resources, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
124 daysmedian FDA review time
159 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K881002 | O.R. SARACAP | Ppg/Applied Resources, Inc. | 1988-08-15 | 159 | 0 |
| K881093 | ICU SARACAP | Ppg/Applied Resources, Inc. | 1988-06-24 | 101 | 0 |
| K882172 | SARACAP AG | Ppg/Applied Resources, Inc. | 1988-06-24 | 31 | 0 |
| K874724 | SARA AGIE MONITOR | Ppg/Applied Resources, Inc. | 1988-03-29 | 132 | 0 |
| K874754 | SARA DIGICAP | Ppg/Applied Resources, Inc. | 1988-03-21 | 124 | 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