Zyno Medical, LLC: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Zyno Medical, LLC” (first 2007, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 147 days. 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 |
|---|---|---|
| 2012 | 1 | 185 |
| 2013 | 1 | 90 |
| 2014 | 2 | 168 |
| 2015 | 0 | — |
| 2016 | 1 | 301 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRN | Pump, Infusion | 5 | 5 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
Review panels
- General Hospital (7)
Most recent Zyno Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153193 | Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) | FRN | 2016-08-30 | 301 |
| K140783 | HALO AMBULATORY INFUSION SYSTEM | FRN | 2014-10-17 | 200 |
| K132841 | ZYNO MEDICAL ADMINISTRATION SET | FPA | 2014-01-23 | 135 |
| K130690 | Z-800 INFUSION SYSTEM | FRN | 2013-06-12 | 90 |
| K120685 | ZYNO MEDICAL ADMINISTRATION SET | FPA | 2012-09-07 | 185 |
| K100705 | ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 | FRN | 2010-07-08 | 118 |
| K071545 | Z-800 VOLUMETRIC INFUSION PUMP | FRN | 2007-10-31 | 147 |
Recalls
16 product recalls in 9 recall events; 9 initiated in the last five years. Most recent: 2025-05-07.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Zyno Medical, LLC (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zyno Medical, LLC?
FDA lists 7 510(k) clearances under the applicant name “Zyno Medical, LLC” (first 2007, latest 2016), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Zyno Medical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zyno Medical, LLC is 147 days.
Which FDA product codes appear under Zyno Medical, LLC?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 5); FPA (Set, Administration, Intravascular, 2).
Next steps
- See all 7 Zyno Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code FRN, Zyno Medical, LLC'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.