510(k) Report

FDA applicant

Smiths Medical Ads, Inc.

Plymouth, MN2 decisions2017–20189 recalls

FDA records 2 decisions for Smiths Medical Ads, Inc. (Plymouth, MN) from 2017 to 2018: 2 510(k) clearances. Most are in product codes MEA (Pump, Infusion, Pca) and BTO (Tube, Tracheostomy (W/Wo Connector)). Its devices cite 3 predicates, 0 of them its own earlier devices. 9 recalls are linked to its devices, 8 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 Ads, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2017: 12018: 1
2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

3in 2025

2022: 1, 1 Class I2024: 5, 4 Class I2025: 3, 3 Class I
2017high 5 (2024) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Smiths Medical Ads, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Smiths Medical Ads, 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?

  • MEAPump, Infusion, Pca1decision
  • BTOTube, Tracheostomy (W/Wo Connector)1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 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.

  • K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid…Smiths Medical Ads, Inc. · 20183cite it
  • K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110…Smiths Medical Ads, Inc. · 20172cite it

What has FDA decided for it lately?

  • K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid…Smiths Medical Ads, Inc. · 20183 Class I recalls
  • K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110…Smiths Medical Ads, Inc. · 20175 Class I recalls

All 2 as Smiths Medical Ads, Inc. →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K170982CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH…Apr 10, 2025Class I
  • K072144CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO…Apr 10, 2025Class I
  • K170982CADD Solis HSPCA PumpApr 10, 2025Class I
  • K170982smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF…Jun 26, 2024Class II
  • K173384smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect…Jun 7, 2024Class I
  • K173384smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect…Jun 7, 2024Class I

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 MD, Inc. 20Smiths Medical Pm, Inc. 5Smiths Medical International, Ltd. 4Smiths Medical 3Smiths Medical International Ltd., Luton 1