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

Landmark Plastics — Predicate Candidate Screening

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

81 daysmedian FDA review time

81 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K760552	THERMOMETER STAND AND DUST COVER	Landmark Plastics	1976-11-12	74
K760495	BASIN, RECTANGULAR WASH	Landmark Plastics	1976-11-12	81
K760517	CUP, DISPOSABLE MEDICINE	Landmark Plastics	1976-11-12	79
K760496	CUP, DISPOSABLE SPECIMEN	Landmark Plastics	1976-11-12	81
K760497	TRAY, SERVICE	Landmark Plastics	1976-11-12	81
K760490	BEDPAN, GENERAL MEDICAL MEDI-PAK	Landmark Plastics	1976-11-12	81
K760494	BASIN, ROUND WASH	Landmark Plastics	1976-11-12	81
K760548	CARAFE AND LINER	Landmark Plastics	1976-11-12	74
K760492	BASIN, LARGE OR SMALL	Landmark Plastics	1976-11-12	81
K760493	DISH, SOAP	Landmark Plastics	1976-11-12	81
K760491	TUMBLER, GENERAL MEDICAL MEDI-PAK	Landmark Plastics	1976-09-15	23
K760551	CANNULA, LARRIAT	Landmark Plastics	1976-09-05	6
K760518	ADAPTER, PER-CEN-TOX-BODY	Landmark Plastics	1976-09-03	8

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