Atlas FDA

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

Cbc Corp. · Predicate Candidate Screening

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

75 daysmedian FDA review time
108 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K832337AUTO-TENS MODEL VCbc Corp.1983-08-31440
K823466AUTO-TENS MODEL III DUAL CHANNEL REPLACECbc Corp.1983-03-071080
K823467AUTO-TENS MODEL I DISPOS. SINGLE CHANCbc Corp.1983-02-07800
K823465AUTO-TENS MODEL II SINGLE CHANNELCbc Corp.1983-02-02750
K823464AUTO-TENS MODEL IV -DUAL CHANNEL FULLCbc Corp.1983-02-02750

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