Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alara, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
276 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102479 | ALARA T210 COMPUTED RADIOGRAPHY SYSTEM | Alara, Inc. | 2011-06-02 | 276 | 0 |
| K071682 | CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T11 | Alara, Inc. | 2007-08-15 | 57 | 0 |
| K062390 | CRYSTALVIEW R200 | Alara, Inc. | 2006-09-18 | 33 | 0 |
| K061538 | ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200 | Alara, Inc. | 2006-06-30 | 28 | 0 |
| K032210 | ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM | Alara, Inc. | 2003-10-02 | 73 | 0 |
| K000162 | METRISCAN BONE DENSITY SYSTEM | Alara, Inc. | 2000-05-12 | 114 | 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