Vesco Medical, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Vesco Medical, LLC” (first 2017, latest 2023), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 251 days. Since 2017 the median was 251 days, against 171 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 |
|---|---|---|
| 2017 | 2 | 140 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 283 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 180 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vesco Medical, LLC took a median 251 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 171 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | 3 | 3 |
| FMF | Syringe, Piston | 1 | 1 |
| LZH | Pump, Infusion, Enteral | 1 | 1 |
Review panels
Most recent Vesco Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230326 | ENFit to ENFit Extension Sets | PIF | 2023-11-02 | 269 |
| K232205 | Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed Set; Vesco Q 40mm Screw Cap Feed Set; Vesco Q ENPlus Feed Set | LZH | 2023-10-23 | 90 |
| K192991 | Vesco Medical Extension Feeding Set | PIF | 2020-08-03 | 283 |
| K170162 | Vesco Medical Nasoenteric Feeding Tubes | PIF | 2017-09-26 | 251 |
| K170218 | Vesco Medical NRFit Tip Syringes | FMF | 2017-02-24 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Vesco Medical, LLC.
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 Vesco Medical, LLC (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via LZH)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via LZH)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vesco Medical, LLC?
FDA lists 5 510(k) clearances under the applicant name “Vesco Medical, LLC” (first 2017, latest 2023), across 3 product codes in 2 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 Vesco Medical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vesco Medical, LLC is 251 days. Since 2017: 251 days, versus 171 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Vesco Medical, LLC?
The most frequent FDA product codes under this applicant name are PIF (Gastrointestinal Tubes With Enteral Specific Connectors, 3); FMF (Syringe, Piston, 1); LZH (Pump, Infusion, Enteral, 1).
Next steps
- See all 5 Vesco Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code PIF, Vesco 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, 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.