Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Erich Jaeger GmbH & Co. KG — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980876 | ASTHMA MONITOR AM2 | Erich Jaeger GmbH & Co. KG | 1998-08-14 | 161 | 0 |
| K954140 | MASTERSCREEN IOS | Erich Jaeger GmbH & Co. KG | 1995-12-14 | 104 | 0 |
| K951901 | MASTERSCREEN PFT BODY | Erich Jaeger GmbH & Co. KG | 1995-07-31 | 98 | 0 |
| K936108 | MASTERSCREEN BODY | Erich Jaeger GmbH & Co. KG | 1995-02-03 | 403 | 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