Atlas FDA

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

Response Biomedical Corp. — Predicate Candidate Screening

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

168 daysmedian FDA review time
591 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K093116MODIFICATION TO: RAMP INFLUENZA A/B ASSAYResponse Biomedical Corp.2009-10-21190
K091235RAMP RSV ASSAYResponse Biomedical Corp.2009-07-24880
K063662RAMP NT-PROBNP ASSAYResponse Biomedical Corp.2008-07-215910
K071591RAMP INFLUENZA A/B ASSAYResponse Biomedical Corp.2008-04-163100
K033745RAMP TROPONIN I ASSAYResponse Biomedical Corp.2004-05-171680
K033747RAMP CK-MB ASSAYResponse Biomedical Corp.2004-05-171680
K012040RAMP MYOGLOBIN ASSAYResponse Biomedical Corp.2001-12-181720

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