SunMed Group Holdings, LLC (specification developer, Grand Rapids, MI): 9 new FDA device listings, incl. blood pressure cuff
SunMed Group Holdings, LLC (Grand Rapids, Michigan): 9 new FDA device listings, incl. blood pressure cuff. Its amount of 9 is top-decile (92nd percentile of 2,570 records). Dated 70 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: 9 · 92th percentile of 2,570 DeviceEstablishmentPulse records · 9.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 24 related MI DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | SunMed Group Holdings, LLC |
| Owner / operator | SunMed Group Holdings, LLC dba AirLife |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Grand Rapids, MI, US |
| New listings | 9 |
| Devices | Blood Pressure Cuff; Tube, Tracheal (W/Wo Connector); Humidifier, Respiratory Gas, (Direct Patient Interface); Mask, Oxygen; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| Product codes | DXQ, BTR, BTT, BYG, CCK |
| Device classes | Class I, Class II |
| Medical specialties | Cardiovascular, Anesthesiology |
| Brand names | Disposable blood pressure cuff; tube, tracheal (w/wo connector) - EasyCurve Endotracheal tube, articulating cord, cuffed (PFEC); Endotrachael Tube, High; Salter Labs Bubble Humidifier; Flex Tip (PFTVPUS); Trach-Vac Endotracheal Tube with Flex Tip/PVC cuff & Stylet (PFTVVCS);; tube, tracheal (w/wo connector) - Salter Labs Trach-Vac Endotracheal Tube; Trach-Vac Endotracheal Tube with; Trach-Vac Endotracheal Tube with Flex Tip/PVC cuff (PFTVVC); Salter Humidifier; CapnoVue Masks |
| First new listing | 2026-05-06 |
| Latest new listing | 2026-08-26 |
| FDA registration number | 1314417 |
| Registration expires | 2027-12-31 |
| amount percentile | 92th of 2,570 (median 1, 9.0x median) |
| Peer records CSV (25 MI 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: 2026-08-26
- 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: SunMed Group Holdings, LLC and 25 Michigan peers
- Michigan DeviceEstablishmentPulse records like this one: 25
- SunMed Group Holdings, LLC's amount: 92nd percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Michigan peer: $5,000 (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 SunMed Group Holdings, LLC in Grand Rapids, Michigan?
SunMed Group Holdings, LLC (Grand Rapids, MI), a specification developer (outsources manufacturing), added 9 FDA device listings between 2026-05-06 and 2026-08-26.
How does SunMed Group Holdings, LLC compare to other Michigan DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 9 is 9.0x the median of 1 across 2,570 records. It is 70 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.
SunMed Group Holdings, LLC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| SunMed Group Holdings, LLC | Grand Rapids, MI | 9 | 92nd | 2026-08-26 |
| Boston Scientific Corporation | Marlborough, MA | 9 | 92nd | 2026-10-16 |
| Sol-Millennium Medical, Inc. | Chicago, IL | 8 | 91st | 2026-09-28 |
| SHOULDER INNOVATIONS, Inc | Grand Rapids, MI | 7 | 90th | 2026-10-15 |
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DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Michigan
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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.