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

Janco Consulting Services — Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K951161MC ACCLAIM Q6000 BEDJanco Consulting Services1995-05-09560
K950058MC HEALTHCARE #CH31 CHILD'S CRIBJanco Consulting Services1995-02-10350
K950059MC INFANT CARE UNIE #PP30Janco Consulting Services1995-02-10350

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