Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IZP — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
58 daysmedian FDA review time
169 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K934944 | MPQ-42 | Elema-Schonander, Inc. | 1993-12-15 | 58 | 0 |
| K911888 | PHILIPS ANGIOPRO | Philips Medical Systems North America, Inc. | 1991-10-15 | 169 | 0 |
| K904144 | PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM | Mallinckrodt Group, Inc. | 1990-12-13 | 97 | 0 |
| K904103 | SEP 90 | Elema-Schonander, Inc. | 1990-11-20 | 75 | 0 |
| K874451 | OMNIPLANE 200 FILM CHANGER SYSTEM | Medrad, Inc. | 1988-02-11 | 106 | 0 |
| K854251 | THE CSE FILM CHANGER SYSTEM | Changer Service & Engineering, Inc. | 1985-10-28 | 6 | 0 |
| K842903 | SEP PROGRAMMER FOR PUCK U & UD FILMCHANG | Elema-Schonander, Inc. | 1984-08-21 | 28 | 0 |
| K841649 | MAXIMAX - 4 | Cgr Medical Corp. | 1984-06-05 | 46 | 0 |
| K841732 | LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM | Sybron Corp. | 1984-06-05 | 40 | 0 |
| K840389 | SEP PROGRAMMER SEP-M/SINGLE-PLANE & | Elema-Schonander, Inc. | 1984-02-21 | 22 | 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