Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Prucka Engineering, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
178 daysmedian FDA review time
355 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993414 | PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 | Prucka Engineering, Inc. | 2000-04-07 | 178 | 0 |
| K960321 | CARDIOCATH CATHETERIZATION LAB SYSTEM | Prucka Engineering, Inc. | 1996-08-21 | 212 | 0 |
| K904747 | PEI PLAQUE ELECTRODE ARRAY | Prucka Engineering, Inc. | 1991-10-09 | 355 | 0 |
| K910307 | CARDIOLAB AMPLIFIER MODULE (CAM) | Prucka Engineering, Inc. | 1991-04-12 | 78 | 0 |
| K902716 | PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP) | Prucka Engineering, Inc. | 1990-09-04 | 76 | 0 |
| K895916 | PE INTERCARDIAC MAPPING SYSTEM (ICMS) | Prucka Engineering, Inc. | 1989-12-13 | 64 | 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