Visicu, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Visicu, Inc.” (first 2000, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 99 days. Since 2017 the median was 99 days, against 172 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 77 |
| 2015 | 0 | — |
| 2016 | 1 | 333 |
| 2017 | 2 | 94 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 421 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Visicu, Inc. took a median 99 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 172 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MSX | System, Network And Communication, Physiological Monitors | 5 | 5 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | 2 |
Review panels
- Cardiovascular (7)
Most recent Visicu, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211046 | eCareManager 4.5 | MSX | 2022-06-03 | 421 |
| K171322 | eCareManager 4.1 | MSX | 2017-08-03 | 90 |
| K171029 | eCareCoordinator | DRG | 2017-07-14 | 99 |
| K153156 | eCareManager 4.0.1 | MSX | 2016-09-30 | 333 |
| K141706 | ECARE COORDINATOR (ECC) | DRG | 2014-09-09 | 77 |
| K012171 | MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS | MSX | 2001-07-24 | 12 |
| K001972 | ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK | MSX | 2000-10-27 | 121 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2015-03-27.
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 Visicu, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Visicu, Inc.” (first 2000, latest 2022), across 2 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 Visicu, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Visicu, Inc. is 99 days. Since 2017: 99 days, versus 172 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Visicu, Inc.?
The most frequent FDA product codes under this applicant name are MSX (System, Network And Communication, Physiological Monitors, 5); DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency, 2).
Next steps
- See all 7 Visicu, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MSX, Visicu, Inc.'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.