Atlas FDA

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

Datachem, Inc. — Predicate Candidate Screening

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

86 daysmedian FDA review time
149 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K900788MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZERDatachem, Inc.1990-07-051350
K834534APSARA ANALYZERDatachem, Inc.1984-03-09780
K823386APSARA CLINICAL DIAG. & INFO. SYSDatachem, Inc.1983-02-09860
K813161FLO TEM II (BLOOD/FLUID WARMERDatachem, Inc.1981-12-09290
K803249FLUID WARMERDatachem, Inc.1981-05-211490

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