Vital Scientific N.V.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Vital Scientific N.V.” (first 1998, latest 2002), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 130 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 |
|---|---|---|---|
| GFO | Activated Partial Thromboplastin | 1 | 1 |
| GGN | Plasma, Coagulation Control | 1 | 1 |
| GJS | Test, Time, Prothrombin | 1 | 1 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 | 1 |
| KQG | Instrument, Coagulation | 1 | 1 |
Review panels
- Hematology (4)
- Clinical Chemistry (1)
Most recent Vital Scientific N.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022021 | VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT | GFO | 2002-11-01 | 134 |
| K021976 | FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON | KQG | 2002-10-25 | 130 |
| K022046 | VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL | GGN | 2002-07-23 | 29 |
| K020840 | VITAL SCIENTIFIC PT WITH CALCIUM | GJS | 2002-05-15 | 61 |
| K973628 | VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA | JJF | 1998-03-13 | 170 |
Recalls
8 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2018-11-15.
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 Diagnostics (Manufacturing) Ptyltd (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 Scientific N.V.?
FDA lists 5 510(k) clearances under the applicant name “Vital Scientific N.V.” (first 1998, latest 2002), 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 Vital Scientific N.V.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vital Scientific N.V. is 130 days.
Which FDA product codes appear under Vital Scientific N.V.?
The most frequent FDA product codes under this applicant name are GFO (Activated Partial Thromboplastin, 1); GGN (Plasma, Coagulation Control, 1); GJS (Test, Time, Prothrombin, 1).
Next steps
- See all 5 Vital Scientific N.V. clearances with predicates and recalls
- Run predicate analysis for product code GFO, Vital Scientific N.V.'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.