510(k) Report

FDA applicant

Halyard Health, Inc.

Alpharetta, GA14 decisions2014–20190 recalls

FDA records 14 decisions for Halyard Health, Inc. (Alpharetta, GA) from 2014 to 2019: 14 510(k) clearances. Most are in product codes GXI (Probe, Radiofrequency Lesion) and LZC (Medical Glove, Specialty). Since 2016 its 510(k)s took a median of 125 days from receipt to decision, against 155 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Halyard Health”.

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 Halyard Health, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2014: 12015: 32016: 52017: 22018: 22019: 1
2014high 5 (2016) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Halyard Health, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Halyard Health, 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?

  • GXIProbe, Radiofrequency Lesion2decisions
  • LZCMedical Glove, Specialty2decisions
  • LZAPolymer Patient Examination Glove2decisions
  • FYAGown, Surgical2decisions
  • KNTTubes, Gastrointestinal (And Accessories)1decision
  • BXNStimulator, Nerve, Battery-Powered1decision

Also: BSO (1), FRG (1), MEB (1), FXX (1).

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 125 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 155 days; 5 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 15 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 1 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.

  • K143287Fluidshield* Surgical Mask with Expanded ChamberHalyard Health, Inc. · 20154cite it
  • K180646Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsHalyard Health · 20183cite it
  • K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health · 20162cite it
  • K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. · 20162cite it
  • K163236COOLIEF Cooled Radiofrequency KitHalyard Health, Inc. · 20161cites it
  • K153708Halyard Black-Orange Powder-Free Nitrile Exam GloveHalyard Health · 20161cites it

What has FDA decided for it lately?

  • K181360ON-Q* Pump with BolusHalyard Health · 2019
  • K180646Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsHalyard Health · 2018
  • K173955Mic-Key* SF Over-the-Wire Stoma Measuring DeviceHalyard Health, Inc. · 2018
  • K162930Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, Inc. · 2017
  • K163461Coolief* Cooled RF ProbeHalyard Health, Inc. · 2017
  • K163236COOLIEF Cooled Radiofrequency KitHalyard Health, Inc. · 2016
  • K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block KitHalyard Health · 2016
  • K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health · 2016

All 7 as Halyard Health, Inc. →All 7 as Halyard Health →

Other applicant names beginning “Halyard”

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

Halyard Health - Irvine 1