Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Schiller AG — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
263 daysmedian FDA review time
447 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221056 | ARGUS PB-3000 | Schiller AG | 2023-07-06 | 451 | 1 |
| K183425 | CARDIOVIT AT-102 G2 | Schiller AG | 2020-03-02 | 447 | 1 |
| K170182 | CARDIOVIT FT-1 | Schiller AG | 2017-07-19 | 177 | 0 |
| K152043 | Diagnostic Station DS20 | Schiller AG | 2016-05-06 | 288 | 0 |
| K101619 | WELCH ALLYN 1500 PATIENT MONITOR | Schiller AG | 2010-11-12 | 156 | 0 |
| K063814 | BP-200 PLUS | Schiller AG | 2007-03-07 | 75 | 0 |
| K053207 | ARGUS, MODEL LCM | Schiller AG | 2006-05-19 | 184 | 0 |
| K051368 | BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM | Schiller AG | 2005-08-09 | 76 | 0 |
| K050686 | CARDIOVIT AT-10PLUS | Schiller AG | 2005-05-04 | 49 | 0 |
| K033738 | MONITORING SYSTEM, MODEL ARGUS PB-2200 | Schiller AG | 2004-08-24 | 270 | 0 |
| K031557 | CARDIOVIT AT-102 | Schiller AG | 2004-04-14 | 331 | 0 |
| K012226 | MONITORING SYSTEM,MODEL ARGUS PB-1000 | Schiller AG | 2002-04-08 | 266 | 0 |
| K992823 | SPIROVIT SP-2, PNEUMOCHECK II | Schiller AG | 2000-05-12 | 263 | 0 |
| K984031 | SPIROVIT, MODEL SP-250 | Schiller AG | 1999-04-30 | 169 | 0 |
| K850702 | CARDIOVIT CS-6 ECG-RECORDER | Schiller AG | 1985-04-25 | 63 | 0 |
| K841254 | CARDIOVIT CV-3 | Schiller AG | 1985-01-24 | 304 | 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