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

Tecan U.S., Ltd. — Predicate Candidate Screening

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

79 daysmedian FDA review time
164 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K933996PROFIBLOTTecan U.S., Ltd.1994-01-281640
K915492RSP MEGA SAMPLE PROCESSORTecan U.S., Ltd.1992-02-21790
K912036ROBOTIC SAMPLE PROCESSORTecan U.S., Ltd.1991-07-26790
K910740SLT MICROPLATE WASHERTecan U.S., Ltd.1991-03-27340
K894126ROBOTIC SAMPLE PROCESSORTecan U.S., Ltd.1989-08-15640
K854406TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500Tecan U.S., Ltd.1986-02-101010

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