Atlas FDA

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

Analytab Products, Inc. — Predicate Candidate Screening

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

31 daysmedian FDA review time
60 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K912965API UNISCEPT KBAnalytab Products, Inc.1991-09-06600
K912964API UNISCEPT MIC/UNISCEPT MICRO-MICAnalytab Products, Inc.1991-08-29520
K861408MODIFIED UNISCEPT KB LABELING AMENDMENTAnalytab Products, Inc.1986-05-16310
K812877PENASEAnalytab Products, Inc.1981-10-26120
K812862API GERM TUBEAnalytab Products, Inc.1981-10-26130

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