Aceso laboratories zolpidem 510(k)?

Short answer:
Aceso Laboratories does not have a 510(k) clearance for a zolpidem‑related device in the FDA database. Zolpidem itself is a prescription medication, not a medical device, and it is regulated under the Drugs part of the Code of Federal Regulations (21 CFR 320), not under the Medical Devices part (21 CFR 820).

Why there is no 510(k) for zolpidem

What you can find instead

1. Drug approval (1998)

   • Drug name: Zolpidem tartrate (brand names: Stilnox®, Zolpida®)
   • Approval date: December 1, 1998
   • Indication: Treatment of insomnia in adults.
   • Regulatory path: 21 CFR 320 (Drugs).

2. If you were looking for a drug‑device combo (e.g., a patch, nasal spray, or oral disintegrating tablet that’s considered a device) – there are no such products from Aceso Laboratories listed in the FDA’s 510(k) database as of the last update (April 2024).

How to verify or look for a 510(k) yourself

1. FDA 510(k) database – Use the advanced search to filter by “Manufacturer name” and “Product description.”
2. Product labels – Check the drug’s label for a “Device” section; if one exists, that’s where the 510(k) clearance would be referenced.
3. FDA Drug and Device databases – The “Drugs@FDA” portal (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) and the “Medical Devices” portal (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) can be cross‑checked.

Bottom line

• No 510(k) for Aceso Laboratories zolpidem device.
• Zolpidem remains a prescription drug approved in 1998.
• If you need more detailed information about the drug itself, the Drugs@FDA portal is the right place. If you think there is a device component, double‑check the product’s label or contact Aceso Laboratories directly.