Atlas FDA

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

Ramco Laboratories, Inc. — Predicate Candidate Screening

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

48 daysmedian FDA review time
296 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K983107VFERamco Laboratories, Inc.1998-10-22480
K981208TFRRamco Laboratories, Inc.1998-10-212020
K910481EPO-RIARamco Laboratories, Inc.1991-11-292960
K872941SPECTRO CRamco Laboratories, Inc.1987-09-04390
K864701VWF IMMUNOBLOTRamco Laboratories, Inc.1987-03-301180
K861159SPECTRO VWFRamco Laboratories, Inc.1986-05-01340
K831470PTH MRRamco Laboratories, Inc.1983-06-22470
K823016CANDIDA DETECTION SYSTEMRamco Laboratories, Inc.1982-12-28770
K812056SPECTRO FEIRITINRamco Laboratories, Inc.1981-08-12220

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