Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cirrus Diagnostics, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
84 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921704 | IMMULITE(R) FSH | Cirrus Diagnostics, Inc. | 1992-06-09 | 60 | 0 |
| K920411 | IMMULITE HLH | Cirrus Diagnostics, Inc. | 1992-03-11 | 40 | 0 |
| K914833 | IMMULITE DIGOXIN | Cirrus Diagnostics, Inc. | 1991-11-22 | 28 | 0 |
| K911796 | IMMULITE(TM) HCG | Cirrus Diagnostics, Inc. | 1991-06-20 | 59 | 0 |
| K910677 | IMMULITE(TM) T-UPTAKE | Cirrus Diagnostics, Inc. | 1991-04-29 | 73 | 0 |
| K910261 | IMMULITE(TM) TOTAL T4 | Cirrus Diagnostics, Inc. | 1991-04-16 | 84 | 0 |
| K905648 | CRP LIPID REAGENT TEST PACK | Cirrus Diagnostics, Inc. | 1991-03-06 | 79 | 0 |
| K905214 | IMMULITE (TM) TOTAL T3 | Cirrus Diagnostics, Inc. | 1991-02-01 | 73 | 0 |
| K905769 | IMMULITE HS-TSH | Cirrus Diagnostics, Inc. | 1991-01-31 | 35 | 0 |
| K905215 | IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER | Cirrus Diagnostics, Inc. | 1991-01-11 | 52 | 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