Atlas FDA

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

GRZ · Predicate Candidate Screening

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

329 daysmedian FDA review time
518 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K946373MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEMZeus Scientific, Inc.1996-02-075180
K944417ZEUA MYCOPLASMAZeus Scientific, Inc.1995-08-013290
K931557FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TESTFuller Laboratories, Inc.1994-03-113460
K861716FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODYWhittaker Bioproducts, Inc.1986-08-08940
K840012INDIRECT FLUORESCENT ANTIBODY MYCOZeus Technologies1984-02-27540

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