Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Propper Manufacturing Co., Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
270 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250306 | Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. | 2025-10-31 | 270 | 0 |
| K240910 | EO Chex Indicator Tape | Propper Manufacturing Co., Inc. | 2024-06-12 | 71 | 0 |
| K222137 | OK Plus Indicator | Propper Manufacturing Co., Inc. | 2022-12-05 | 139 | 0 |
| K212592 | Gas-Chex Indicator | Propper Manufacturing Co., Inc. | 2022-01-20 | 157 | 0 |
| K210866 | Steri-Dot Process Indicator | Propper Manufacturing Co., Inc. | 2021-06-21 | 90 | 0 |
| K210553 | Steam-Dot Process Indicator | Propper Manufacturing Co., Inc. | 2021-05-19 | 83 | 0 |
| K141638 | PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE | Propper Manufacturing Co., Inc. | 2014-09-17 | 90 | 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