# Chalgren Enterprises, Inc.

- Location (FDA's records): Gilroy, CA
- FDA decisions: 21 (1989–1999): 21 510(k) clearances
- Product codes: IKT (9), GXY (8), JXE (2), HLT (1), GXZ (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 16 (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
- Technomed Europe: 6 (https://510kreport.com/company/technomed-europe)
- Nicolet Biomedical, Inc.: 4 (https://510kreport.com/company/nicolet-biomedical)
- Rochester Electro Medical, Inc.: 3 (https://510kreport.com/company/rochester-electro-medical)
- Specialized Laboratory Equipment, Ltd.: 3 (https://510kreport.com/company/specialized-laboratory-equipment)

## Its most-cited devices
- K912282: Disposable Monopolar Needle Electrode, Var Models (1992), cited by 3
- K953887: RE-Usable Concentric Needle (1995), cited by 2
- K955335: Disposable Hypodermic Monopolar Needle Recording Electrode (1996), cited by 2
- K960591: RE-Usable Bipolar Concentric Needle (237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP (1996), cited by 2
- K924521: Disposable Concentric Needle Electrode (1993), cited by 2
- K953886: RE-Usable Monopolar Needle (1995), cited by 2

## Recent decisions
- K982950: Fine Wire Electrode Mmodel Numbers 221-14-730, 221-24-730, 221-14-550, 221-24-550 (Jun 22, 1999)
- K960591: RE-Usable Bipolar Concentric Needle (237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP (Jun 13, 1996)
- K955335: Disposable Hypodermic Monopolar Needle Recording Electrode (Jan 29, 1996)
- K953354: Emg Disc Recording Electrode (Jan 22, 1996)
- K953356: Emg Recording Ring Electrode (Jan 22, 1996)
- K953361: Emg Disc Recording Electrode (Jan 22, 1996)
- K952908: Emg Disc Recording Electrode with Pin (Dec 6, 1995)
- K952690: Emg Disc Recording Electrode with Pin (Dec 6, 1995)

Source page: https://510kreport.com/company/chalgren-enterprises