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

Protos Laboratories — Predicate Candidate Screening

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

49 daysmedian FDA review time
52 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K802177GOAT ANTI-HUMAN IGMProtos Laboratories1980-10-31520
K802196GOAT ANTI-HUMAN COMPLEMENT C4Protos Laboratories1980-10-31510
K802257GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFICProtos Laboratories1980-10-31450
K791560GOAT ANTI-HUMAN C-REACTIVE PROTEINProtos Laboratories1979-09-24380
K791605GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSINProtos Laboratories1979-09-04150
K791115GOAR ANTI-HUMAN LAMBODA CHAINProtos Laboratories1979-08-03490

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