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

Latex Ind., Inc. — Predicate Candidate Screening

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

64 daysmedian FDA review time
83 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K812058AKRON URINARY DRAINAGE BATLatex Ind., Inc.1981-07-31100
K810281UROLOGICAL CATHETERSLatex Ind., Inc.1981-02-25230
K791674BLADDER RETENTION CATHETERIZATION TRAYLatex Ind., Inc.1979-11-05700
K781751CATHETER, AKRON FOLEY TEFLONLatex Ind., Inc.1979-01-22980
K781433AKRON MALE EXTERNAL CATHETERLatex Ind., Inc.1978-11-03740
K772277BLADDER RETENTION-CATHETHERIZATIONTRAYLatex Ind., Inc.1978-03-02830
K780267CATH TRAY W/OUT CATHETERLatex Ind., Inc.1978-02-2470
K772340CATHETERIZATION KIT 732016-732018Latex Ind., Inc.1978-02-24640
K772342ROBINSON KIT - 750014 & 750016Latex Ind., Inc.1978-02-24640
K780268BLADDER CATH KIT W/OUT CATHETERLatex Ind., Inc.1978-02-2470
K772341BLADDER KIT - 734000Latex Ind., Inc.1978-02-24640
K771651AKRO-SIL FOLEY KIT 5CCLatex Ind., Inc.1977-09-20220
K771652CATH-CARE TRAYLatex Ind., Inc.1977-09-20220
K771650AKRO-SIL FOLEY KIT 30CCLatex Ind., Inc.1977-09-20220

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