Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Osypka Medical, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
301 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123916 | PSA SERIES | Osypka Medical, Inc. | 2013-04-09 | 111 | 0 |
| K082242 | ICON, MODEL C3 | Osypka Medical, Inc. | 2008-10-08 | 62 | 0 |
| K081035 | AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION C | Osypka Medical, Inc. | 2008-05-30 | 49 | 0 |
| K070985 | AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC | Osypka Medical, Inc. | 2008-02-01 | 301 | 0 |
| K033130 | PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR | Osypka Medical, Inc. | 2003-10-31 | 31 | 0 |
| K022939 | OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3 | Osypka Medical, Inc. | 2002-10-03 | 29 | 0 |
| K020896 | OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, S | Osypka Medical, Inc. | 2002-06-14 | 87 | 2 |
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