510(k) Report

FDA applicant

Cardinal Health 200, Inc.

Waukegan, IL4 decisions2006–20267 recalls

FDA records 4 decisions for Cardinal Health 200, Inc. (Waukegan, IL) from 2006 to 2026: 4 510(k) clearances. Most are in product codes FYA (Gown, Surgical) and KGO (Surgeon'S Gloves). Its devices cite 3 predicates, 0 of them its own earlier devices. 7 recalls are linked to its devices.

FDA’s records also spell it “Cardinal Health 200, LLC”.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Cardinal Health 200, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2015: 12016: 12026 (partial year): 1
2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2021

2020: 62021: 1
2007high 6 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cardinal Health 200, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cardinal Health 200, 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?

  • FYAGown, Surgical3decisions
  • KGOSurgeon'S Gloves1decision

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 2 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.

  • K151778Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingCardinal Health 200, Inc. · 20161cites it
  • K061308Trimax, Model 9515N, Breathable Surgical Gown, Models 3247AN and 9015N and Optima or Surgical Gown, Model…Cardinal Health 200, Inc. · 20061cites it

What has FDA decided for it lately?

  • K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLC · 2026
  • K151778Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingCardinal Health 200, Inc. · 2016
  • K150151SmartGownTM surgical gownCardinal Health 200, Inc. · 20151 recall
  • K061308Trimax, Model 9515N, Breathable Surgical Gown, Models 3247AN and 9015N and Optima or Surgical Gown, Model…Cardinal Health 200, Inc. · 20066 recalls

All 3 as Cardinal Health 200, Inc. →The one decision as Cardinal Health 200, LLC →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K150151SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474Nov 2, 2021Class II
  • K061308AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NAJan 11, 2020Class II
  • K061308AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NAJan 11, 2020Class II
  • K061308AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NAJan 11, 2020Class II
  • K061308AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NBJan 11, 2020Class II
  • K061308AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NBJan 11, 2020Class II

Other applicant names beginning “Cardinal”

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

Cardinal Health, Inc. 28Cardinal Health200, LLC 26Cardinal Health, Alaris Products 9Cardinal Health-Medical Products and Services 6Cardinal Health 207, Inc. 5Cardinal Spine, LLC 4Cardinal Health 303,Inc. 4Cardinal Health Germany 234 GmbH 2Cardinal Scale Mfg. Co. 1