Autonomous Medical Devices Incorporated (manufacturer, Santa Ana, CA): 5 new FDA device listings, incl. assayed external control material for microbiology nucleic acid amplif
Autonomous Medical Devices Incorporated (Santa Ana, California): 5 new FDA device listings, incl. assayed external control material for microbiology nucleic acid amplif. Its amount of 5 is above the median of 1 (87th percentile). Dated 141 days ago, it serves as a historical benchmark. Score 85/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 5 · 87th percentile of 2,570 DeviceEstablishmentPulse records · 5.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 283 related CA DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Autonomous Medical Devices Incorporated |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device |
| Location | Santa Ana, CA, US |
| New listings | 5 |
| Devices | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays; Respiratory Virus Panel Nucleic Acid Assay System; Real Time Nucleic Acid Amplification System; Influenza A And Influenza B Multiplex Nucleic Acid Assay; Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents |
| Product codes | PMN, OCC, OOI, OZE, QOF |
| Device classes | Class II |
| Medical specialties | Microbiology, Clinical Chemistry |
| Brand names | Fast PCR Instrument; Fast PCR Mini Respiratory Panel Positive External Control; Fast PCR Mini Respiratory Panel; Fast PCR Mini Respiratory Panel Negative External Control |
| First new listing | 2026-06-16 |
| Latest new listing | 2026-06-16 |
| FDA registration number | 3023999024 |
| Registration expires | 2026-12-31 |
| amount percentile | 87th of 2,570 (median 1, 5.0x median) |
| Peer records CSV (284 CA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-06-16
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Autonomous Medical Devices Incorporated and 284 California peers
- California DeviceEstablishmentPulse records like this one: 284
- Autonomous Medical Devices Incorporated's amount: 87th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $56,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
85 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Autonomous Medical Devices Incorporated in Santa Ana, California?
Autonomous Medical Devices Incorporated (Santa Ana, CA), a manufacturer, added 5 FDA device listings on 2026-06-16.
How does Autonomous Medical Devices Incorporated compare to other California DeviceEstablishmentPulse records?
Its amount of 5 sits in the upper half (87th percentile) of 2,570 records; the median is 1. It is 141 days old; check the official source for later updates before acting. Its Score of 85/100 puts it among the stronger signals in this feed.
Autonomous Medical Devices Incorporated vs. top 2 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Autonomous Medical Devices Incorporated | Santa Ana, CA | 5 | 87th | 2026-06-16 |
| Inquis Medical, Inc. | Menlo Park, CA | 5 | 87th | 2026-10-16 |
| Endovascular Engineering, Inc. | Menlo Park, CA | 3 | 77th | 2026-10-14 |
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.