Vitaid, Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Vitaid, Ltd.” (first 1989, latest 2005), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 92 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 3 | 3 |
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 1 | 1 |
| EZL | Catheter, Retention Type, Balloon | 1 | 1 |
| KOD | Catheter, Urological | 1 | 1 |
| KPM | Shunt, Peritoneal | 1 | 1 |
Review panels
Most recent Vitaid, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050803 | PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES | BTR | 2005-06-30 | 92 |
| K932647 | WIRE REINFORCED ENDOTRACHEAL TUBE | BTR | 1993-11-02 | 153 |
| K901738 | SELFCATH | KOD | 1990-06-27 | 71 |
| K894883 | PHYCON ALL SILICONE BALLOON CATHETER | EZL | 1990-04-25 | 267 |
| K894794 | AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP | KPM | 1989-11-21 | 116 |
| K894669 | LASER SHIELDING TUBE | BTR | 1989-10-13 | 81 |
| K894337 | UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM | CBI | 1989-09-29 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Vitaid, Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Vitaid, Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Vitaid, Ltd.” (first 1989, latest 2005), across 5 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 Vitaid, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vitaid, Ltd. is 92 days.
Which FDA product codes appear under Vitaid, Ltd.?
The most frequent FDA product codes under this applicant name are BTR (Tube, Tracheal (W/Wo Connector), 3); CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector), 1); EZL (Catheter, Retention Type, Balloon, 1).
Next steps
- See all 7 Vitaid, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BTR, Vitaid, Ltd.'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.