510(k) Report

FDA applicant

Smiths Medical MD, Inc.

St. Paul, MN20 decisions2004–201249 recalls

FDA records 20 decisions for Smiths Medical MD, Inc. (St. Paul, MN) from 2004 to 2012: 20 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and LJT (Port & Catheter, Implanted, Subcutaneous…). Its devices cite 21 predicates, 4 of them its own earlier devices. 49 recalls are linked to its devices, 10 Class I.

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 Smiths Medical MD, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 32008: 52009: 12010: 12011: 12012: 1
2007high 5 (2008) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

2in 2025

2007: 12008: 82010: 12011: 22012: 1, 1 Class I2013: 12014: 12015: 32016: 12017: 32018: 22019: 2, 1 Class I2020: 3, 2 Class I2022: 4, 3 Class I2023: 4, 1 Class I2024: 10, 1 Class I2025: 2, 1 Class I
2007high 10 (2024) · low 0 (2009)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • FPASet, Administration, Intravascular4decisions
  • LJTPort & Catheter, Implanted, Subcutaneous, Intravascular4decisions
  • FRNPump, Infusion4decisions
  • MRZAccessories, Pump, Infusion3decisions
  • LZGPump, Infusion, Insulin2decisions
  • MEAPump, Infusion, Pca1decision

Also: DYB (1), FMI (1).

Whose devices does it build on?

Its devices cite 21 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 times; 4 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.

  • K040636Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and Extension SetSmiths Medical MD, Inc. · 20043cite it
  • K051568Cadd-MS 3 Ambulatory Infusion PumpSmiths Medical MD, Inc. · 20053cite it
  • K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power Gripper Plus NeedleSmiths Medical MD, Inc. · 20073cite it
  • K072144Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - AdministratorSmiths Medical MD, Inc. · 20082cite it
  • K062323Deltec Cozmo Insulin Infusion Pump with Cozmonitor Blood Glucose Meter, Models 21-1815, 21-1816, 21-1817Smiths Medical MD, Inc. · 20062cite it
  • K060036Port-a-Cath, Port-a-Cath II, Proport and P.a.S. Port Implantable Venous Access Systems with Dual Layer…Smiths Medical MD, Inc. · 20062cite it

What has FDA decided for it lately?

  • K112407Smith Medical Peel-Away Sheath IntroducersSmiths Medical MD, Inc. · 2012
  • K111386Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported…Smiths Medical MD, Inc. · 20116 Class I recalls
  • K101180Gripper Micro Blunt Cannula, Non-Coring Safety Needle (Gripper Micro Needle) Model: 21-3253-24, 21-3258-24…Smiths Medical MD, Inc. · 2010
  • K091181Lockbox for Use with Medfusion 3000 Series PumpsSmiths Medical MD, Inc. · 2009
  • K082783Cadd -Solis Medication Safety Software: Administrator and Point-of-CareSmiths Medical MD, Inc. · 2008
  • K081156Cadd Medication Cassette ReservoirSmiths Medical MD, Inc. · 20081 Class I recall
  • K080743Lockbox for Use with Cadd Solis Infusion PumpSmiths Medical MD, Inc. · 2008
  • K072144Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - AdministratorSmiths Medical MD, Inc. · 20082 Class I recalls

All 20 as Smiths Medical MD, Inc. →

What has been recalled?

49 recalls linked to its devices; the latest:

  • K040636Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented…Aug 6, 2025Class II
  • K072144CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO…Apr 10, 2025Class I
  • K081156CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24Jun 26, 2024Class II
  • K081156CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24Jun 26, 2024Class II
  • K081156CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24Jun 26, 2024Class II
  • K081156ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28Jun 26, 2024Class II

Other applicant names beginning “Smiths”

FDA records each applicant name separately; these may or may not be the same firm.

Smiths Medical Asd, Inc. 53Smiths Industries Medical Systems, Inc. 23Smiths Medical Pm, Inc. 5Smiths Medical International, Ltd. 4Smiths Medical 3Smiths Medical Ads, Inc. 2Smiths Medical International Ltd., Luton 1