Atlas FDA

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

Carr Microbiologicals — Predicate Candidate Screening

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

14 daysmedian FDA review time
14 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K812467PGUA-INDOL MICROTUBECarr Microbiologicals1981-09-14140
K812469RAPID DECARBOXYLASE/DIHYDROLASE MICROTUBCarr Microbiologicals1981-09-14140
K812466ONPX-INDOL MEDIUM MICROTUBESCarr Microbiologicals1981-09-14140
K812465PHOS MICROTUBESCarr Microbiologicals1981-09-14140
K812470HIPP MICROTUBECarr Microbiologicals1981-09-14140
K812468PYRR MICROTUBECarr Microbiologicals1981-09-14140

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