# Makrite Industries, Inc.

- Location (FDA's records): New Taipei, TW
- FDA decisions: 4 (2002–2026): 4 510(k) clearances
- Product codes: FXX (3), MSH (1)
- 510(k) review time since 2016: median 109 days, against 142 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (0 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
- Louis M. Gerson Co., Inc.: 1 (https://510kreport.com/company/louis-m-gerson)
- Rizhao Sanqi Medical & Health Articles Co., Ltd.: 1 (https://510kreport.com/company/rizhao-sanqi-medical-health-articles)
- Wuhan Dymex Healthcare Co., Ltd.: 1 (https://510kreport.com/company/wuhan-dymex-healthcare)
- Anqing Mayfield Medical Limited: 1 (https://510kreport.com/company/anqing-mayfield-medical)

## Recent decisions
- K252650: Disposable Medical Face Mask (Jan 5, 2026)
- K240258: Disposable Medical Face Mask (M643BE) (Apr 18, 2024)
- K220550: Disposable Surgical Face Mask (M663BE, M663BT) (Jun 14, 2022)
- K020474: Makrite Type N95 Respirator and Surgical Mask Model 910-N95 (Jul 23, 2002)

Source page: https://510kreport.com/company/makrite-industries