Atlas FDA

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

Louis M. Gerson Co., Inc. — Predicate Candidate Screening

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

173 daysmedian FDA review time
477 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K061375RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730Louis M. Gerson Co., Inc.2006-11-171840
K050193GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATORLouis M. Gerson Co., Inc.2005-04-11740
K960778ISOLAIR APR TYPE N95Louis M. Gerson Co., Inc.1996-05-09730
K925185ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MASLouis M. Gerson Co., Inc.1994-02-034770
K931288ISOLAIR 2 FULL FACE SPLASH GUARDLouis M. Gerson Co., Inc.1994-01-213150
K922507GERSON ISOLAIR APR PARTICULATE SURGICAL MASKLouis M. Gerson Co., Inc.1992-11-161730
K881910LABELING CHANGE TO SURGICAL FACE MASKLouis M. Gerson Co., Inc.1988-05-18190
K802373SURGICAL FACE MASKLouis M. Gerson Co., Inc.1980-11-12440

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