Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Schiller America, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
152 daysmedian FDA review time
421 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973751 | MT-200 | Schiller America, Inc. | 1998-08-25 | 328 | 0 |
| K973735 | MICROVIT MT-100 | Schiller America, Inc. | 1998-08-25 | 329 | 0 |
| K970879 | CARDIOVIT CS-200 | Schiller America, Inc. | 1997-06-25 | 107 | 0 |
| K953396 | CARDIOVIT AT-1C, AT-2C | Schiller America, Inc. | 1995-12-19 | 152 | 0 |
| K954066 | MINISCOPE MS-3 | Schiller America, Inc. | 1995-10-27 | 58 | 0 |
| K941462 | CARDIOVIT AT-5C | Schiller America, Inc. | 1995-05-19 | 421 | 0 |
| K946205 | CARDIOVIT AT-1, P-80 | Schiller America, Inc. | 1995-03-16 | 85 | 0 |
| K914970 | CARDIOVIT CS-100 | Schiller America, Inc. | 1992-11-03 | 364 | 0 |
| K896120 | SCHILLER MODEL SP-100 SPIROVIT(TM) | Schiller America, Inc. | 1990-01-09 | 77 | 0 |
| K896121 | SCHILLER MODEL SP-200 SPIROVIT(TM) | Schiller America, Inc. | 1990-01-09 | 77 | 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