Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sita, Inc. · Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

73 daysmedian FDA review time
100 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K872700YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGENSita, Inc.1987-10-151000
K872701RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROLSita, Inc.1987-09-18730
K872694YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGENSita, Inc.1987-09-18730
K872698ADENOVIRUS CF ANTIGEN AND CONTROL ANTIGENSita, Inc.1987-09-18730
K872693INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGENSita, Inc.1987-09-18730
K872699MUMPS CF ANTIGEN AND CONTROL ANTIGENSita, Inc.1987-09-18730
K872697PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGENSita, Inc.1987-09-18730
K872695PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGENSita, Inc.1987-09-18730
K872696PARAINFLUENZA-3-CF ANTIGEN AND CONTROL ANTIGENSita, Inc.1987-09-18730

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