Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alltech Medical Systems America, Inc. — 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) |
|---|---|---|---|---|---|
| K163192 | Comfort EC710 | Alltech Medical Systems America, Inc. | 2017-04-10 | 146 | 0 |
| K141945 | ECHOSTAR COMFORT 1.5T MRI | Alltech Medical Systems America, Inc. | 2015-02-03 | 201 | 0 |
| K113511 | ECHOSTAR SPICA 1.5T MR SYSTEM | Alltech Medical Systems America, Inc. | 2012-05-02 | 156 | 1 |
| K082100 | ALLTECH ECHOSTAR 1.5 T MR SYSTEM | Alltech Medical Systems America, Inc. | 2008-08-06 | 12 | 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