DeviceEstablishmentPulse / report

SUNSET HEALTHCARE SOLUTIONS, Inc. (repackager or relabeler, Chicago, IL): 3 new FDA device listings, incl. device, positive pressure breathing, intermittent

SUNSET HEALTHCARE SOLUTIONS, Inc. (Chicago, Illinois): 3 new FDA device listings, incl. device, positive pressure breathing, intermittent. Its amount of 3 is above the median of 1 (77th percentile). Dated 64 days ago, it serves as a historical benchmark. Score 65/100. 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: 3 · 77th percentile of 2,570 DeviceEstablishmentPulse records · 3.0x the median

Free preview: all 15 published fields of this record are shown below. Locked: 94 related IL DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentSUNSET HEALTHCARE SOLUTIONS, Inc.
Owner / operatorSunset Healthcare Solutions
RoleRepackager or relabeler
Establishment typesRepack or Relabel Medical Device; Complaint File Establishment per 21 CFR 820.198
LocationChicago, IL, US
New listings3
DevicesDevice, Positive Pressure Breathing, Intermittent; Bandage, Liquid, Skin Protectant; Protector, Skin Pressure
Product codesNHJ, NEC, FMP
Device classesClass I, Class II
Medical specialtiesAnesthesiology, General Hospital
Brand namesCough Assist; Petroleum-free skin protectant/moisturizing emollient; Sunset Nasal Gel Pad
First new listing2026-05-07
Latest new listing2026-09-01
FDA registration number3006446479
Registration expires2026-12-31
amount percentile77th of 2,570 (median 1, 3.0x median)
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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: 2026-09-01
  • Data refreshed: 2026-10-28
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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: SUNSET HEALTHCARE SOLUTIONS, Inc. and 95 Illinois peers

  • Illinois DeviceEstablishmentPulse records like this one: 95
  • SUNSET HEALTHCARE SOLUTIONS, Inc.'s amount: 77th percentile of 2,570 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every Illinois peer: $19,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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65 / 100 Score

  • Class II or III devices: QMS and regulatory demands.
  • Several new listings at once.
  • U.S. establishment.

What is the DeviceEstablishmentPulse record for SUNSET HEALTHCARE SOLUTIONS, Inc. in Chicago, Illinois?

SUNSET HEALTHCARE SOLUTIONS, Inc. (Chicago, IL), a repackager or relabeler, added 3 FDA device listings between 2026-05-07 and 2026-09-01.

How does SUNSET HEALTHCARE SOLUTIONS, Inc. compare to other Illinois DeviceEstablishmentPulse records?

Its amount of 3 sits in the upper half (77th percentile) of 2,570 records; the median is 1. It is 64 days old; check the official source for later updates before acting.

SUNSET HEALTHCARE SOLUTIONS, Inc. vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
SUNSET HEALTHCARE SOLUTIONS, Inc.Chicago, IL377th2026-09-01
Nam Ha Viet Nam Trading Company LimitedHanoi Ha Noi, VN377th2026-09-24
Tpc Advanced Technology, Inc.City Industry, CA483rd2026-09-28
VIVE Health LLCNaples, FL1093rd2026-10-14

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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.

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