Vital Diagnostics (Manufacturing) Ptyltd: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Vital Diagnostics (Manufacturing) Ptyltd” (first 2010, latest 2012), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 118 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 | 174 |
| 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 |
|---|---|---|---|
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| CJY | Azo Dye, Calcium | 1 | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | 1 |
| KHS | Enzymatic, Carbon-Dioxide | 1 | 1 |
Review panels
Most recent Vital Diagnostics (Manufacturing) Ptyltd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120626 | EON CALCIUM REGENT | CJY | 2012-08-22 | 174 |
| K112416 | CPK REAGENT | CGS | 2011-11-09 | 79 |
| K111063 | VITAL SERUM CONTROLS | JJY | 2011-06-28 | 71 |
| K110394 | ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) | JIX | 2011-06-09 | 118 |
| K100060 | EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 | KHS | 2010-12-15 | 338 |
Recalls
openFDA lists no recalls under a recalling firm named Vital Diagnostics (Manufacturing) Ptyltd.
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.
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.
- Vital Signs, Inc. (75 510(k)s)
- Vital Images, Inc. (41 510(k)s)
- Vital Metrics, Inc. (9 510(k)s)
- Vital Scientific N.V. (5 510(k)s)
- Vital Concepts, Inc. (4 510(k)s)
- Vital Art and Science Incorporated (2 510(k)s)
- Vital Connections, Inc. (2 510(k)s)
- Vital Signs, Inc., A GE Healthcare Company (2 510(k)s)
- Vital 5 (1 510(k)s)
- Vital Access (1 510(k)s)
- Vital Air Oxygen Co. (1 510(k)s)
- Vital Canada, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vital Diagnostics (Manufacturing) Ptyltd?
FDA lists 5 510(k) clearances under the applicant name “Vital Diagnostics (Manufacturing) Ptyltd” (first 2010, latest 2012), across 5 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 Vital Diagnostics (Manufacturing) Ptyltd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vital Diagnostics (Manufacturing) Ptyltd is 118 days.
Which FDA product codes appear under Vital Diagnostics (Manufacturing) Ptyltd?
The most frequent FDA product codes under this applicant name are CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes, 1); CJY (Azo Dye, Calcium, 1); JIX (Calibrator, Multi-Analyte Mixture, 1).
Next steps
- See all 5 Vital Diagnostics (Manufacturing) Ptyltd clearances with predicates and recalls
- Run predicate analysis for product code CGS, Vital Diagnostics (Manufacturing) Ptyltd'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.