# Nanofiber Solutions, LLC

- Location (FDA's records): Dublin, OH
- FDA decisions: 6 (2018–2025): 6 510(k) clearances
- Names in FDA's records: Nanofiber Solutions, LLC (5); Nanofiber Solutions, Inc. (1)
- Product codes: MAI (4), OWW (1), QSZ (1)
- 510(k) review time since 2016: median 29 days, against 47 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 10 (6 its own); citations of its devices by later devices: 6 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Embody, Inc.: 1 (https://510kreport.com/company/embody)
- Cayenne Medical, Inc.: 1 (https://510kreport.com/company/cayenne-medical)
- W. L. Gore & Associates, Inc.: 1 (https://510kreport.com/company/w-l-gore-associates)
- Polymedics Innovations, GmbH: 1 (https://510kreport.com/company/polymedics-innovations)

## Its most-cited devices
- K183236: Rotium Bioresorbable Wick (2019), cited by 3
- K201414: Rotium Bioresorbable Wick (2020), cited by 2
- K231641: Rotium Bioresorbable Wick (2023), cited by 1

## Recent decisions
- K250021: Rotium (Feb 27, 2025)
- K241912: Biocharge (Jul 29, 2024)
- K231641: Rotium Bioresorbable Wick (Jul 5, 2023)
- K201414: Rotium Bioresorbable Wick (Jun 25, 2020)
- K183236: Rotium Bioresorbable Wick (Mar 11, 2019)
- K173544: Phoenix Wound Matrix (Mar 2, 2018)

Source page: https://510kreport.com/company/nanofiber-solutions