510(k) Report

FDA applicant

Icu Medical, Inc.

San Clemente, CA72 decisions1984–2026376 recalls

FDA records 72 decisions for Icu Medical, Inc. (San Clemente, CA) from 1984 to 2026: 72 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FMG (Stopcock, I.V. Set). Since 2016 its 510(k)s took a median of 261 days from receipt to decision, against 221 for FDA’s reviews in the same codes and years. Its devices cite 68 predicates, 37 of them its own earlier devices. 376 recalls are linked to its devices, 10 Class I.

FDA’s records also spell it “Icu Medical”, “ICU Medical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Icu Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

5in 2025

2007: 52008: 42009: 32010: 22013: 12014: 12016: 22017: 12018: 22019: 12020: 22023: 32025: 52026 (partial year): 4
2007high 5 (2007) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

12in 2026

2011: 22012: 42013: 502014: 4, 4 Class I2015: 82016: 102017: 632018: 292019: 22, 4 Class I2020: 962021: 162022: 62024: 12025: 49, 2 Class I2026 (partial year): 12
2007high 96 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Icu Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Icu Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FPASet, Administration, Intravascular27decisions
  • FMGStopcock, I.V. Set5decisions
  • ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System4decisions
  • FMINeedle, Hypodermic, Single Lumen4decisions
  • FRNPump, Infusion4decisions
  • FMFSyringe, Piston4decisions

Also: PHC (3), LHI (2), QBP (2), DQO (2), KNT (2), FEG (1).

How long do its 510(k) reviews take?

Since 2016, its 12 510(k)s took a median of 261 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 221 days; 4 of its 12 were faster than that.

Whose devices does it build on?

Its devices cite 68 predicates; 37 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 75 times; 37 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K970855Clave ConnectorIcu Medical, Inc. · 199715cite it
  • K915571Clave ConnectorIcu Medical, Inc. · 19927cite it
  • K964435Primary IV SetIcu Medical, Inc. · 19975cite it
  • K070532SpirosIcu Medical, Inc. · 20074cite it
  • K941190Clave Needle-Less Connector Open Extension SetIcu Medical, Inc. · 19954cite it
  • K915171Lopez Valve TM IIIcu Medical, Inc. · 19924cite it

What has FDA decided for it lately?

  • K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU Medical · 2026
  • K252130LifeShield Infusion Safety Software SuiteIcu Medical, Inc. · 2026
  • K252006OTTO™ Disinfecting CapIcu Medical, Inc. · 2026
  • K251980ClaveQS™ BagIcu Medical, Inc. · 2026
  • K250616Clave™ Neutral-Displacement Needlefree ConnectorsIcu Medical, Inc. · 2025
  • K242114Plum Solo™ Precision IV PumpIcu Medical, Inc. · 20253 recalls
  • K242117LifeShield Infusion Safety Software SuiteIcu Medical, Inc. · 20252 recalls
  • K242115Plum Duo™ Precision IV PumpIcu Medical, Inc. · 20252 recalls

All 66 as Icu Medical, Inc. →All 5 as Icu Medical →The one decision as ICU Medical →

What has been recalled?

376 recalls linked to its devices; the latest:

  • K223607ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number…Jun 10, 2026Class II
  • K242114ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pumpJun 10, 2026Class II
  • K964435IV Sets with drip chambersMay 12, 2026Class II
  • K131549Oncology sets with drip chambersMay 12, 2026Class II
  • K081361Oncology sets with drip chambersMay 12, 2026Class II
  • K081361IV Sets with drip chambersMay 12, 2026Class II