Atlas FDA

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

Laurimed, LLC — Predicate Candidate Screening

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

84 daysmedian FDA review time
111 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K1632473.3 mm Laurimed Microdebrider; 4.0 mm Laurimed MicrodebriderLaurimed, LLC2017-03-091110
K161101PolypVac Microdebrider (3.3mm and 4.0mm)Laurimed, LLC2016-06-22640
K133133LAURIMED POLYPVAC MICRODEBRIDERLaurimed, LLC2013-12-23841
K091818LAURIMED SPINAL INJECTION SYSTEMLaurimed, LLC2009-09-23970
K090815PERCUTANEOUS DISCECTOMY SYSTEMLaurimed, LLC2009-05-21570
K083909SPINAL INJECTION SYSTEMLaurimed, LLC2009-03-18780
K082194LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002Laurimed, LLC2008-08-28240
K080140LAURIMED SPINAL INJECTION SYSTEMLaurimed, LLC2008-05-091080

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