Atlas FDA

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

Facet Technologies, LLC — Predicate Candidate Screening

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

69 daysmedian FDA review time
128 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K232912Facet Aurora Reusable Lancet BaseFacet Technologies, LLC2024-01-251280
K223370NeatNick Heel Safety LancetFacet Technologies, LLC2023-02-131010
K223099Facet Manatee Reusable Lancing BaseFacet Technologies, LLC2022-11-28590
K222539Facet Blood LancetsFacet Technologies, LLC2022-11-18880
K221433Facet 28G Universal LancetFacet Technologies, LLC2022-07-15590
K141749CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOFacet Technologies, LLC2014-07-29290
K140568CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINTFacet Technologies, LLC2014-05-13690

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