ADVANCED INSTRUMENTATIONS, INC.
Registration 1066270FEI 3000957797Miami, FL
Owner/operator: ADVANCED INSTRUMENTATIONS, INC.
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Device in the United States for Export Only
- Manufacture Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 91
- Added, last 12 months
- 11
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 91
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| MQG | NeoGenesisAccessory, Assisted ReproductionAdded Jan 27, 2026 | Class 2 | 21 CFR 884.6120 | — |
| CCK | PM-2000M Patient MonitorAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class 2 | 21 CFR 868.1400 | K132077 |
| CCK | PM-2000XLAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class 2 | 21 CFR 868.1400 | K120631 |
| CBQ | PM-2000XLAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | Class 2 | 21 CFR 868.1500 | K120631 |
| CBQ | PM-2000M Patient MonitorAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | Class 2 | 21 CFR 868.1500 | K132077 |
| CBS | PM-2000M Patient MonitorAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | Class 2 | 21 CFR 868.1620 | K132077 |
| CBS | PM-2000XLAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | Class 2 | 21 CFR 868.1620 | K120631 |
| CBR | PM-2000XLAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | Class 2 | 21 CFR 868.1700 | K120631 |
| CBR | PM-2000M Patient MonitorAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | Class 2 | 21 CFR 868.1700 | K132077 |
| CCL | PM-2000XLAnalyzer, Gas, Oxygen, Gaseous-Phase | Class 2 | 21 CFR 868.1720 | K120631 |
| CCL | PM-2000M Patient MonitorAnalyzer, Gas, Oxygen, Gaseous-Phase | Class 2 | 21 CFR 868.1720 | K132077 |
| NZG | 007-P Baby BasinettBassinet, Hospital | Class 2 | 21 CFR 880.5145 | — |
and 79 more on your full dossier
What changed
- Jan 27, 2026Listing added: MQG — NeoGenesis
- Jan 27, 2026Listing added: DPS — ECG-12 Max
- Apr 24, 2026Listing added: DPS — ECG-1515ST
- Jun 17, 2026Listing added: BSZ — AM-6000+ Anesthesia Machine
- Jan 27, 2026Listing added: FMZ — NeoNest
- Dec 2, 2025Listing added: MHX — PM-2000TEL Telemetry System
- Jan 27, 2026Listing added: HGM — FM-8000
- Jan 27, 2026Listing added: HGM — FM-3000 Plus
- Mar 23, 2026Listing added: ITX — DUS-5000+
- Jan 27, 2026Listing added: LBI — PT-5000 NeoLight
- Dec 2, 2025Listing added: BZD — A3150 Neonatal CPAP