# Maxigen Biotech, Inc.

- Location (FDA's records): Taoyuan, TW
- FDA decisions: 5 (2011–2026): 5 510(k) clearances
- Product codes: KGN (3), OLR (1), NUC (1)
- 510(k) review time since 2016: median 373 days, against 162 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 2 (1 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
- Biocore: 1 (https://510kreport.com/company/biocore)
- Collagen Matrix, Inc.: 1 (https://510kreport.com/company/collagen-matrix)
- Church & Dwight Co., Inc.: 1 (https://510kreport.com/company/church-dwight)

## Firms that cite its devices most
- Coreleader Biotech Co., Ltd.: 1 (https://510kreport.com/company/coreleader-biotech)

## Its most-cited devices
- K100927: Surgiaid (2011), cited by 2

## Recent decisions
- K253989: HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST) (Sep 3, 2026)
- K242100: SurgiAid Collagen Wound Dressing  (HA) (Oct 16, 2025)
- K230529: HealiAid Dental Collagen Wound Dressing (Nov 22, 2023)
- K223126: SurgiAid® Collagen Wound Dressing (Oct 11, 2023)
- K100927: Surgiaid (Feb 2, 2011)

Source page: https://510kreport.com/company/maxigen-biotech