Atlas FDA

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

GNS — Predicate Candidate Screening

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

11 daysmedian FDA review time
17 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K780696GOAT ANTIINFLUENZA ANTISERA AUSSRNortheast Biomedical Labs., Inc.1978-05-0390
K780697GOAT ANTI-INFLUENZA ANTISERA ATEXASNortheast Biomedical Labs., Inc.1978-05-0390
K780277INFLUENZA HI PRESERUM A/TEXASFlow Laboratories, Inc.1978-02-28110
K780273INFLUENZA HI PRESERUMFlow Laboratories, Inc.1978-02-28110
K780276INFLUENZA HI ANTISERUM A/TEXASFlow Laboratories, Inc.1978-02-28110
K780274INFLUENZA HI ANTISERUMFlow Laboratories, Inc.1978-02-28110
K780004GOAT ANTI-INFLUENZA ANTISERANortheast Biomedical Labs., Inc.1978-01-20170
K780006GOAT ANTI-INFLUENZA ANTISERANortheast Biomedical Labs., Inc.1978-01-20170
K780005GOAT ANTI-INFLUENZA ANTISERANortheast Biomedical Labs., Inc.1978-01-20170

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