Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Arizant Healthcare, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
110 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120412 | 3M SPOTON TEMPERATURE MONITORING SYSTEM | Arizant Healthcare, Inc. | 2012-05-30 | 110 | 0 |
| K082217 | RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM | Arizant Healthcare, Inc. | 2008-10-06 | 61 | 0 |
| K060939 | RANGER IRRIGATION FLUID WARMING SYSTEM | Arizant Healthcare, Inc. | 2006-06-26 | 81 | 1 |
| K060865 | BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 | Arizant Healthcare, Inc. | 2006-04-24 | 25 | 4 |
| K053645 | MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS | Arizant Healthcare, Inc. | 2006-03-09 | 69 | 4 |
| K041686 | BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM | Arizant Healthcare, Inc. | 2004-06-30 | 8 | 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