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

Westmark Hospital Supplies · Predicate Candidate Screening

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

88 daysmedian FDA review time

444 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K914934	HAND PACK	Westmark Hospital Supplies	1993-01-21	444
K914928	BASIC SET UP TRAY	Westmark Hospital Supplies	1992-03-16	133
K914929	LACERATION TRAY	Westmark Hospital Supplies	1992-01-31	88
K914927	DRESSING CHANGE KIT	Westmark Hospital Supplies	1992-01-31	88
K914935	HEART PACK II	Westmark Hospital Supplies	1992-01-31	88
K914932	SUTURE REMOVAL KIT	Westmark Hospital Supplies	1992-01-31	88
K914933	HEART PACK III	Westmark Hospital Supplies	1992-01-31	88

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