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

Genesis Industries, Inc. · Predicate Candidate Screening

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

68 daysmedian FDA review time
103 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K994361ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTGenesis Industries, Inc.2000-02-18530
K962828EVERT-ITGenesis Industries, Inc.1997-02-102060
K880377NOVO VIVO MODEL #17140 AND #17135Genesis Industries, Inc.1988-04-04680
K880376NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAPGenesis Industries, Inc.1988-02-16200
K833287SATIN CAST ECONOCASTGenesis Industries, Inc.1984-01-031030
K833290C & B 40 PENTRO C & B40Genesis Industries, Inc.1984-01-031030
K833278C & B 45Genesis Industries, Inc.1983-12-29980
K833289C & B 61 PENTRON C & B61Genesis Industries, Inc.1983-12-29980
K833280SUPRA AP CHOICE 83Genesis Industries, Inc.1983-12-26950
K833285RX IV PENTRON IVGenesis Industries, Inc.1983-12-22910
K833288C & B57 PENTRON C & B57Genesis Industries, Inc.1983-12-20890
K833286RX SEG ECONOPLUSGenesis Industries, Inc.1983-11-28670
K833284RX 41 PENTRON 41Genesis Industries, Inc.1983-11-28670
K833281RX D PENTRONGenesis Industries, Inc.1983-11-28670
K833283RX ORY PENTRON C & BGenesis Industries, Inc.1983-11-28670
K833279NATURELLE-LITEGenesis Industries, Inc.1983-11-28670
K833282RX NYSP PENTRON 60Genesis Industries, Inc.1983-11-28670

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