Icu Medical, Inc. (specification developer, Lake Forest, IL): 45 new FDA device listings, incl. pump, infusion
Icu Medical, Inc. (Lake Forest, Illinois): 45 new FDA device listings, incl. pump, infusion. Its amount of 45 is top-decile (99th percentile of 2,570 records). Dated 106 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: 45 · 99th percentile of 2,570 DeviceEstablishmentPulse records · 45.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 94 related IL DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Icu Medical, Inc. |
| 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 | Lake Forest, IL, US |
| New listings | 45 |
| Devices | Pump, Infusion; Warmer, Blood, Non-Electromagnetic Radiation; Set, Administration, Intravascular; System, Thermal Regulating; Warmer, Thermal, Infusion Fluid; Accessories, Pump, Infusion; Pump, Infusion, Pca; Device, Warming. Blood And Plasma; Medical Device Data System; Infusion Safety Management Software |
| Product codes | FRN, BSB, FPA, DWJ, LGZ, MRZ, MEA, KZL, OUG, PHC |
| Device classes | Class I, Class II |
| Medical specialties | General Hospital, Hematology, Cardiovascular |
| Brand names | Pump, infusion; Warmer, blood, non-electromagnetic radiation; Set, administration, intravascular; System, thermal regulating; Warmer, thermal, infusion fluid; Accessories, pump, infusion; Pump, infusion, pca; DEVICE, WARMING. BLOOD AND PLASMA |
| First new listing | 2026-07-13 |
| Latest new listing | 2026-07-21 |
| FDA registration number | 3013319212 |
| Registration expires | 2026-12-31 |
| amount percentile | 99th of 2,570 (median 1, 45.0x median) |
| Peer records CSV (95 IL 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: 2026-07-21
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (IL first): MEDLINE INDUSTRIES, LP - Northfield (specification developer · Isomedix Operations, Inc. (contract sterilizer, Libertyville · Maya Medical Top Trade Ltd. (foreign exporter, Tsofit Centra · Sterigenics US LLC (contract sterilizer, Gurnee, IL) · Donson Machine Company (contract manufacturer, Alsip, IL) · Browse all by state and category →
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: Icu Medical, Inc. and 95 Illinois peers
- Illinois DeviceEstablishmentPulse records like this one: 95
- Icu Medical, Inc.'s amount: 99th 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)
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 Icu Medical, Inc. in Lake Forest, Illinois?
Icu Medical, Inc. (Lake Forest, IL), a specification developer (outsources manufacturing), added 45 FDA device listings between 2026-07-13 and 2026-07-21.
How does Icu Medical, Inc. compare to other Illinois DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 45 is 45.0x the median of 1 across 2,570 records. It is 106 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.
Icu Medical, Inc. vs. top 2 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Icu Medical, Inc. | Lake Forest, IL | 45 | 99th | 2026-07-21 |
| Sol-Millennium Medical, Inc. | Chicago, IL | 8 | 91st | 2026-09-28 |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL | 144 | 99th | 2026-10-08 |
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DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Illinois
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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.