Atlas FDA

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

Nanofiber Solutions, LLC — Predicate Candidate Screening

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

30 daysmedian FDA review time
111 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250021RotiumNanofiber Solutions, LLC2025-02-27550
K241912BIOCHARGENanofiber Solutions, LLC2024-07-29280
K231641Rotium Bioresorbable WickNanofiber Solutions, LLC2023-07-05300
K201414Rotium Bioresorbable WickNanofiber Solutions, LLC2020-06-25270
K183236Rotium Bioresorbable WickNanofiber Solutions, LLC2019-03-111110

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