# American Threshold Industries, Inc.

- Location (FDA's records): Enka, NC
- FDA decisions: 20 (1980–1997): 20 510(k) clearances
- Product codes: FYC (4), FYF (2), KME (2), FRG (2), KKX (2), LDQ (1), HAX (1), FXX (1), NAB (1), FMW (1), FXP (1), HOY (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Crosstex Intl.: 2 (https://510kreport.com/company/crosstex-intl)
- Cardinal Health200, LLC: 2 (https://510kreport.com/company/cardinal-health200)
- Crosstex International: 1 (https://510kreport.com/company/crosstex-international)

## Its most-cited devices
- K801036: Surgical Mask (1980), cited by 2
- K952116: Cover Gown (1995), cited by 1
- K952115: Barrier Gown, Kool-Gard Backless Gown (1995), cited by 1
- K830473: Nova Gauze (1983), cited by 1

## Recent decisions
- K971483: Secure-Wrap (TM) Sterilization Wrap (Jun 24, 1997)
- K953879: Surgeon's Cap (Jan 5, 1996)
- K953878: Bouffant Cap (Jan 5, 1996)
- K952115: Barrier Gown, Kool-Gard Backless Gown (Sep 25, 1995)
- K952114: Kool Gard Singles Gown (Sep 25, 1995)
- K952116: Cover Gown (Sep 5, 1995)
- K934085: Modification of Surgical Eyeshield Mask (Nov 12, 1993)
- K915530: Nova Gauze (R) Disposable Nonwoven Sponges, Sterile (Aug 17, 1992)

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