ICU Medical: FDA 510(k) clearances across all its applicant names
FDA lists 316 510(k) clearances, 1 PMA and 0 De Novo decision across the 19 applicant names Caduvo groups under ICU Medical, first 1977, latest 2026. Median 510(k) review time across these names: 87 days. Since 2017 the median was 257 days, against 169 days for all cleared 510(k)s in the same product codes. Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 130 |
| 2013 | 4 | 283 |
| 2014 | 2 | 122 |
| 2015 | 0 | — |
| 2016 | 3 | 187 |
| 2017 | 6 | 167 |
| 2018 | 10 | 264 |
| 2019 | 2 | 376 |
| 2020 | 3 | 332 |
| 2021 | 2 | 172 |
| 2022 | 0 | — |
| 2023 | 3 | 265 |
| 2024 | 1 | 254 |
| 2025 | 5 | 257 |
| 2026 | 4 | 268 |
The 19 FDA applicant names in this group
| Applicant name | 510(k) clearances | PMA | De Novo | Years |
|---|---|---|---|---|
| Icu Medical, Inc. | 72 | 0 | 0 | 1984–2026 |
| Smiths Medical Asd, Inc. | 52 | 1 | 0 | 2004–2024 |
| Pharmacia Deltec, Inc. | 43 | 0 | 0 | 1987–1995 |
| Sims Deltec, Inc. | 32 | 0 | 0 | 1995–2001 |
| Concord/Portex | 23 | 0 | 0 | 1989–1993 |
| Portex, Inc. | 20 | 0 | 0 | 1977–2004 |
| Smiths Medical MD, Inc. | 20 | 0 | 0 | 2004–2012 |
| Sims Portex, Inc. | 12 | 0 | 0 | 1998–2001 |
| Deltec Systems, Inc. | 9 | 0 | 0 | 1984–1987 |
| Portex , Ltd. | 7 | 0 | 0 | 2003–2004 |
| Deltec, Inc. | 5 | 0 | 0 | 2002–2003 |
| Smiths Medical Pm, Inc. | 5 | 0 | 0 | 2007–2009 |
| Sims Portex , Ltd. | 4 | 0 | 0 | 2000–2002 |
| Smiths Medical | 3 | 0 | 0 | 2004–2019 |
| Smiths Medical International , Ltd. | 3 | 0 | 0 | 2005–2013 |
| Sims Level 1, Inc. | 2 | 0 | 0 | 2000–2001 |
| Smiths Medical Ads, Inc. | 2 | 0 | 0 | 2017–2018 |
| Smiths Medical International | 1 | 0 | 0 | 2006–2006 |
| Smiths Medical International Ltd., Luton | 1 | 0 | 0 | 2005–2005 |
Review time against the same product codes
Since 2017, 510(k)s cleared under these names took a median 257 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 169 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 52 | 52 |
| FRN | Pump, Infusion | 34 | 34 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 22 | 22 |
| FMI | Needle, Hypodermic, Single Lumen | 14 | 14 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 10 | 10 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 9 | 9 |
| JOH | Tube Tracheostomy And Tube Cuff | 9 | 9 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 9 | 9 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 7 | 7 |
| MEA | Pump, Infusion, Pca | 6 | 6 |
Plus 70 more product codes.
Review panels
- General Hospital (194)
- Anesthesiology (77)
- Cardiovascular (16)
- Clinical Chemistry (10)
- Gastroenterology and Urology (8)
- Obstetrics and Gynecology (7)
- General and Plastic Surgery (2)
- Dental (1)
- Ear, Nose and Throat (1)
Most recent ICU Medical 510(k) clearances
| 510(k) | Device | Applicant name | Product code | Decision date | Review days |
|---|---|---|---|---|---|
| K262532 | NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) | Icu Medical, Inc. | LGZ | 2026-09-18 | 58 |
| K252130 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | PHC | 2026-04-02 | 269 |
| K252006 | OTTO Disinfecting Cap | Icu Medical, Inc. | QBP | 2026-03-27 | 273 |
| K251980 | ClaveQS Bag | Icu Medical, Inc. | KPE | 2026-03-20 | 266 |
| K250616 | Clave Neutral-Displacement Needlefree Connectors | Icu Medical, Inc. | FPA | 2025-06-05 | 97 |
| K242117 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | PHC | 2025-04-02 | 257 |
| K242115 | Plum Duo Precision IV Pump | Icu Medical, Inc. | FRN | 2025-04-02 | 257 |
| K242114 | Plum Solo Precision IV Pump | Icu Medical, Inc. | FRN | 2025-04-02 | 257 |
| K243985 | Rio Drug Reconstitution Transfer Device | Icu Medical, Inc. | LHI | 2025-01-22 | 30 |
| K232943 | Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe | Smiths Medical Asd, Inc. | QNQ | 2024-05-31 | 254 |
306 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P900052 | PMA | PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYSTEM | 1991-04-22 |
Recalls
1,320 product recalls in 260 recall events under these names; 231 initiated in the last five years.
Recalling firms are matched to the applicant names above by name only, so recalls filed under other names are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
How this group is built
Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.
Smiths Medical (January 2022; formerly SIMS, incl. Portex and Deltec). Includes filings made before the acquisition. Left out: Hospira — ICU Medical bought only Hospira Infusion Systems from Pfizer (2017); the HOSPIRA name also covers businesses Pfizer kept.
Sources
Frequently asked questions
How many FDA 510(k) clearances are listed across ICU Medical's applicant names?
FDA lists 316 510(k) clearances, 1 PMA and 0 De Novo decision across the 19 applicant names Caduvo groups under ICU Medical, first 1977, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.
Which FDA applicant names does ICU Medical file under?
The names with the most 510(k) clearances in this group are Icu Medical, Inc. (72); Smiths Medical Asd, Inc. (52); Pharmacia Deltec, Inc. (43); Sims Deltec, Inc. (32); Concord/Portex (23). The full list of 19 names is on this page.
How long does FDA take to clear ICU Medical 510(k)s?
The median time from FDA receipt to decision across 510(k)s cleared under these names is 87 days. Since 2017 the median was 257 days, against 169 days for all cleared 510(k)s in the same product codes.
Does the ICU Medical count include acquired companies?
Yes. A group includes filings an acquired business made under its own name, including before the acquisition. Businesses that were sold are left out, and names whose ownership is unclear are not included. FDA does not group applicants; the sources for each grouping are listed on this page.
Next steps
- See all 316 ICU Medical clearances with predicates and recalls
- Run predicate analysis for product code FPA, ICU Medical's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls). Applicant names are matched exactly, with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this grouping or data.
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