# Icu Medical, Inc. (specification developer, San Clemente, CA): 223 new FDA device listings, incl. tube, tracheostomy (w/wo connector)

**Score:** 85/100

| 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 | San Clemente, CA, US |
| New listings | 223 |
| Devices | Tube, Tracheostomy (W/Wo Connector); Oximeter; Set, Administration, Intravascular; Port & Catheter, Implanted, Subcutaneous, Intravascular; Transducer, Blood-Pressure, Extravascular; Probe, Blood-Flow, Extravascular; Needle, Spinal, Short Term; Needle, Conduction, Anesthetic (W/Wo Introducer); Filter, Conduction, Anesthetic; Anesthesia Conduction Kit |
| Product codes | BTO, DQA, FPA, LJT, DRS, DPT, MIA, BSP, BSN, CAZ, BSY, CAH, BTR, BYE, BTL |
| Device classes | Class I, Class II |
| Medical specialties | Anesthesiology, Cardiovascular, General Hospital, Clinical Chemistry, General, Plastic Surgery, Ear, Nose, Throat, Gastroenterology, Urology, Physical Medicine |
| Brand names | Tube, tracheostomy (w/wo connector); Oximeter; Set, administration, intravascular; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR; Transducer, blood-pressure, extravascular; PROBE, BLOOD-FLOW, EXTRAVASCULAR; NEEDLE, SPINAL, SHORT TERM; CATHETERS, SUCTION, TRACHEOBRONCHIAL |
| First new listing | 2026-07-15 |
| Latest new listing | 2026-07-22 |
| FDA registration number | 2025816 |
| Registration expires | 2026-12-31 |

## Why this 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.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
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.