Icu Medical, Inc.: FDA clearances and approvals
Icu Medical, Inc. has 72 FDA 510(k) clearances (first 1984, latest 2026), across 24 product codes in 4 review panels. Median 510(k) review time: 114 days. Since 2017 its median was 261 days, against 175 days for all cleared 510(k)s in the same product codes. openFDA lists 656 product recalls by a recalling firm named Icu Medical, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 58 |
| 2014 | 1 | 167 |
| 2015 | 0 | — |
| 2016 | 2 | 238 |
| 2017 | 1 | 109 |
| 2018 | 2 | 433 |
| 2019 | 1 | 266 |
| 2020 | 2 | 294 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 3 | 265 |
| 2024 | 0 | — |
| 2025 | 5 | 257 |
| 2026 | 4 | 268 |
Review time against the same product codes
Since 2017, Icu Medical, Inc.'s cleared 510(k)s took a median 261 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 175 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 27 | 27 |
| FMG | Stopcock, I.V. Set | 5 | 5 |
| FMF | Syringe, Piston | 4 | 4 |
| FMI | Needle, Hypodermic, Single Lumen | 4 | 4 |
| FRN | Pump, Infusion | 4 | 4 |
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | 4 | 4 |
| PHC | Infusion Safety Management Software | 3 | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 2 |
| LHI | Set, I.V. Fluid Transfer | 2 | 2 |
Plus 14 more product codes.
Review panels
Most recent Icu Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262532 | NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) | LGZ | 2026-09-18 | 58 |
| K252130 | LifeShield Infusion Safety Software Suite | PHC | 2026-04-02 | 269 |
| K252006 | OTTO Disinfecting Cap | QBP | 2026-03-27 | 273 |
| K251980 | ClaveQS Bag | KPE | 2026-03-20 | 266 |
| K250616 | Clave Neutral-Displacement Needlefree Connectors | FPA | 2025-06-05 | 97 |
| K242117 | LifeShield Infusion Safety Software Suite | PHC | 2025-04-02 | 257 |
| K242115 | Plum Duo Precision IV Pump | FRN | 2025-04-02 | 257 |
| K242114 | Plum Solo Precision IV Pump | FRN | 2025-04-02 | 257 |
| K243985 | Rio Drug Reconstitution Transfer Device | LHI | 2025-01-22 | 30 |
| K232048 | Cogent Hemodynamic Monitoring System; Cogent HMS | DXG | 2023-12-20 | 163 |
62 earlier clearances. See the full list in Caduvo.
Recalls
656 product recalls in 68 recall events; 93 initiated in the last five years. Most recent: 2026-08-20.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Icu Medical, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Icu Medical, Inc. have?
Icu Medical, Inc. has 72 FDA 510(k) clearances (first 1984, latest 2026), across 24 product codes in 4 review panels.
How long does FDA take to clear Icu Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Icu Medical, Inc.'s cleared 510(k)s is 114 days. Since 2017: 261 days, versus 175 days for all cleared 510(k)s in the same product codes.
What devices does Icu Medical, Inc. make?
Its most frequent FDA product codes are FPA (Set, Administration, Intravascular, 27); FMG (Stopcock, I.V. Set, 5); FMF (Syringe, Piston, 4).
Has Icu Medical, Inc. had device recalls?
openFDA lists 656 product recalls in 68 recall events by a recalling firm whose name matches Icu Medical, Inc; the most recent began 2026-08-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 72 Icu Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Icu Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.