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

Silimed, LLC — Predicate Candidate Screening

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

70 daysmedian FDA review time

252 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K981852	SILIMED TISSUE EXPANDER	Silimed, LLC	1998-08-05	71
K974479	SILIMED VAGINAL STENT	Silimed, LLC	1998-08-05	252
K981835	SILIMED MALAR IMPLANT	Silimed, LLC	1998-07-09	44
K981851	SILIMED SILICONE CARVING BLOCK	Silimed, LLC	1998-07-09	44
K981850	SILIMED CHIN IMPLANTS	Silimed, LLC	1998-07-09	44
K981833	SILIMED NASAL L SHAPED IMPLANT	Silimed, LLC	1998-06-26	31
K980221	SILIMED NASAL RETAINER	Silimed, LLC	1998-04-02	70
K974480	SILIMED CALF IMPLANT	Silimed, LLC	1998-02-24	90
K974482	SILIMED GLUTEAL IMPLANT	Silimed, LLC	1998-02-24	90

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