Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Propper Mfg. Co., Inc. — Predicate Candidate Screening
25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
410 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111453 | STEAM DOT BLU PROCESS INDICATOR | Propper Mfg. Co., Inc. | 2012-04-05 | 316 | 0 |
| K102894 | CLASSIX CHEMICAL STERILIZATION INDICATOR | Propper Mfg. Co., Inc. | 2011-05-25 | 237 | 0 |
| K082620 | ONCE-A-DAY VERTOS TEST PACK | Propper Mfg. Co., Inc. | 2009-07-08 | 302 | 0 |
| K031152 | PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENG | Propper Mfg. Co., Inc. | 2004-08-17 | 494 | 0 |
| K991618 | BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR | Propper Mfg. Co., Inc. | 2001-01-24 | 624 | 0 |
| K991276 | PASS/FAIL CHALLENGE PACK | Propper Mfg. Co., Inc. | 1999-07-12 | 89 | 0 |
| K973585 | PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR | Propper Mfg. Co., Inc. | 1998-11-06 | 410 | 0 |
| K972747 | BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320) | Propper Mfg. Co., Inc. | 1998-01-09 | 170 | 0 |
| K961156 | ONCE-A-DAY BOWIE AND DICK TEST PACK. | Propper Mfg. Co., Inc. | 1997-04-01 | 375 | 0 |
| K921798 | PROPPER SUPER SERACULT(R) | Propper Mfg. Co., Inc. | 1992-10-05 | 174 | 0 |
| K915804 | PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM. | Propper Mfg. Co., Inc. | 1992-03-20 | 87 | 0 |
| K903024 | BI-O.K. STEAM TEST-PAK | Propper Mfg. Co., Inc. | 1990-09-12 | 64 | 0 |
| K895910 | STEAMLINE | Propper Mfg. Co., Inc. | 1990-08-22 | 316 | 0 |
| K891784 | BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR | Propper Mfg. Co., Inc. | 1990-02-09 | 322 | 0 |
| K871672 | STERILIZATION INDICATOR FOR FLASH STERILIZATION | Propper Mfg. Co., Inc. | 1987-06-01 | 34 | 0 |
| K851804 | BIO-CHALLENGE TEST PAK | Propper Mfg. Co., Inc. | 1985-07-16 | 77 | 0 |
| K834353 | OK FLASH STERILIZATION INDICATOR | Propper Mfg. Co., Inc. | 1984-03-19 | 97 | 0 |
| K834297 | PROPPER SERACULT | Propper Mfg. Co., Inc. | 1984-01-27 | 50 | 0 |
| K821648 | GAS CHEX PLASTIC BAG | Propper Mfg. Co., Inc. | 1982-06-22 | 18 | 0 |
| K813204 | SERACULT OCCULT BLOOF TEST | Propper Mfg. Co., Inc. | 1982-01-28 | 76 | 0 |
| K810506 | PROPPER SIGMOIDOSCOPE SUCTION INSTRUMENT | Propper Mfg. Co., Inc. | 1981-04-07 | 42 | 0 |
| K802428 | PROPPER SHARPGUARD & TRAYPAD STERIL. AID | Propper Mfg. Co., Inc. | 1980-10-23 | 17 | 0 |
| K771919 | FIBER OPTICS SIGMOIDOSCOPE | Propper Mfg. Co., Inc. | 1977-10-20 | 8 | 0 |
| K771920 | FIBER OPTICS PROCTOSCOPE | Propper Mfg. Co., Inc. | 1977-10-20 | 8 | 0 |
| K771918 | FIBEO OPTICS ILLUM. SYSTEM | Propper Mfg. Co., Inc. | 1977-10-20 | 8 | 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