Data Critical Corp.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Data Critical Corp.” (first 1997, latest 2001), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 71 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 |
|---|---|---|---|
| MSX | System, Network And Communication, Physiological Monitors | 9 | 9 |
| DPS | Electrocardiograph | 1 | 1 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
Review panels
- Cardiovascular (11)
Most recent Data Critical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013156 | MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM | MSX | 2001-10-19 | 28 |
| K012005 | MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM | MSX | 2001-07-24 | 27 |
| K011999 | MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM | MSX | 2001-07-24 | 27 |
| K011436 | MOBILE-PATIENT VIEWER | DPS | 2001-07-05 | 56 |
| K010912 | ALARMVIEW WIRELESS DATA NETWORK SYSTEM | MSX | 2001-04-05 | 9 |
| K003998 | FLEXVIEW CLINICAL MONITORING SYSTEM | MSX | 2001-03-07 | 71 |
| K992848 | ALARMVIEW SYSTEM | MSX | 1999-11-19 | 87 |
| K990378 | STATVIEW SYSTEM | MSX | 1999-09-20 | 224 |
| K973527 | CARDIO-PAGER SYSTEM | MSX | 1998-03-31 | 194 |
| K971650 | RHYTHMSTAT XL | DXH | 1997-12-04 | 212 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Data Critical Corp..
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.
- Data Medical Associates, Inc. (111 510(k)s)
- Data Ray (1 510(k)s)
- Data Sciences Intl., Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Data Critical Corp.?
FDA lists 11 510(k) clearances under the applicant name “Data Critical Corp.” (first 1997, latest 2001), across 3 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 Data Critical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Data Critical Corp. is 71 days.
Which FDA product codes appear under Data Critical Corp.?
The most frequent FDA product codes under this applicant name are MSX (System, Network And Communication, Physiological Monitors, 9); DPS (Electrocardiograph, 1); DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 1).
Next steps
- See all 11 Data Critical Corp. clearances with predicates and recalls
- Run predicate analysis for product code MSX, Data Critical Corp.'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.