Scottcare Corporation: FDA clearances and approvals
Scottcare Corporation has 6 FDA 510(k) clearances (first 1990, latest 2014), across 5 product codes in 1 review panel. Median 510(k) review time: 140 days. openFDA lists 2 product recalls by a recalling firm named Scottcare Corporation.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 126 |
| 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 2 | 2 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 | 1 |
| DRN | Device, Counter-Pulsating, External | 1 | 1 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Scottcare Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142180 | TELESENSE | DSI | 2014-12-12 | 126 |
| K092947 | TELESENTRY, MODEL TS01 | DSI | 2010-02-26 | 155 |
| K083382 | CHROMA, MODEL: RZ153C | MWJ | 2009-08-13 | 272 |
| K081359 | GENESIS ECP | DRN | 2008-05-29 | 14 |
| K050778 | TELEREHAD 2004 | DRG | 2005-04-13 | 16 |
| K895719 | TELEREHAB SYSTEM FOR CARDIAC REHABILITATION | DXH | 1990-03-06 | 162 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2016-02-25.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Scottcare Corporation have?
Scottcare Corporation has 6 FDA 510(k) clearances (first 1990, latest 2014), across 5 product codes in 1 review panel.
How long does FDA take to clear Scottcare Corporation's 510(k)s?
The median time from FDA receipt to decision across Scottcare Corporation's cleared 510(k)s is 140 days.
What devices does Scottcare Corporation make?
Its most frequent FDA product codes are DSI (Detector And Alarm, Arrhythmia, 2); DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency, 1); DRN (Device, Counter-Pulsating, External, 1).
Has Scottcare Corporation had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Scottcare Corporation; the most recent began 2016-02-25. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Scottcare Corporation clearances with predicates and recalls
- Run predicate analysis for product code DSI, Scottcare Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.