Halyard Health: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Halyard Health” (first 2014, latest 2019), across 10 product codes in 4 review panels. Median 510(k) review time under this name: 148 days. Since 2017 the median was 125 days, against 129 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 176 |
| 2015 | 3 | 147 |
| 2016 | 5 | 151 |
| 2017 | 2 | 154 |
| 2018 | 2 | 68 |
| 2019 | 1 | 304 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Halyard Health took a median 125 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FYA | Gown, Surgical | 2 | 2 |
| GXI | Probe, Radiofrequency Lesion | 2 | 2 |
| LZA | Polymer Patient Examination Glove | 2 | 2 |
| LZC | Medical Glove, Specialty | 2 | 2 |
| BSO | Catheter, Conduction, Anesthetic | 1 | 1 |
| BXN | Stimulator, Nerve, Battery-Powered | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| MEB | Pump, Infusion, Elastomeric | 1 | 1 |
Review panels
Most recent Halyard Health 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181360 | ON-Q* Pump with Bolus | MEB | 2019-03-22 | 304 |
| K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | LZC | 2018-06-27 | 107 |
| K173955 | Mic-Key* SF Over-the-Wire Stoma Measuring Device | KNT | 2018-01-26 | 29 |
| K162930 | Aero Chrome* Select Breathable Performance Surgical Gowns | FYA | 2017-04-21 | 184 |
| K163461 | Coolief* Cooled RF Probe | GXI | 2017-04-13 | 125 |
| K163236 | COOLIEF Cooled Radiofrequency Kit | GXI | 2016-12-16 | 29 |
| K161232 | ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit | BSO | 2016-09-30 | 151 |
| K160709 | HALYARD* PURPLE NITRILE XTRA* Powder-Free Exam Gloves | LZC | 2016-09-06 | 176 |
| K153255 | Aero Chrome* Breathable Performance Surgical Gown | FYA | 2016-04-13 | 155 |
| K153708 | Halyard Black-Orange Powder-Free Nitrile Exam Glove | LZA | 2016-03-31 | 99 |
4 earlier clearances. See the full list in Caduvo.
Recalls
57 product recalls in 10 recall events; 0 initiated in the last five years. Most recent: 2018-02-07.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Halyard Health is the lead sponsor of 6 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02591537: OxyGenesys Dissolved Oxygen Dressing; Abdominoplasty at Northwestern University (Completed, started 2015-10)
- NCT02343003: Nerve Ablation by Cooled Radiofrequency Compared to Corticosteroid Injection for Management of Knee Pain (Completed, started 2015-01)
- NCT01263054: Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back Pain (Completed, started 2010-12)
- NCT00673712: Multicenter Infection Surveillance Study Following Open Heart Surgery (Completed, started 2008-04)
- NCT00653133: Multicenter Continuous Peripheral Nerve Block Surveillance Study (Completed, started 2007-05)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Halyard Health (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MEB)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MEB)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Halyard Health - Irvine (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Halyard Health?
FDA lists 14 510(k) clearances under the applicant name “Halyard Health” (first 2014, latest 2019), across 10 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Halyard Health?
The median time from FDA receipt to decision across 510(k)s cleared under the name Halyard Health is 148 days. Since 2017: 125 days, versus 129 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Halyard Health?
The most frequent FDA product codes under this applicant name are FYA (Gown, Surgical, 2); GXI (Probe, Radiofrequency Lesion, 2); LZA (Polymer Patient Examination Glove, 2).
Next steps
- See all 14 Halyard Health clearances with predicates and recalls
- Run predicate analysis for product code FYA, Halyard Health's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.