Cas Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 32 510(k) clearances under the applicant name “Cas Medical Systems, Inc.” (first 1985, latest 2019), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 120 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 | 120 |
| 2013 | 2 | 114 |
| 2014 | 2 | 122 |
| 2015 | 2 | 83 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 128 |
| 2019 | 1 | 255 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cas Medical Systems, Inc. took a median 192 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 182 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MUD | Oximeter, Tissue Saturation | 9 | 9 |
| DQA | Oximeter | 6 | 6 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 6 | 6 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 5 | 5 |
| FMT | Warmer, Infant Radiant | 2 | 2 |
| BYI | Percussor, Powered-Electric | 1 | 1 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| DXW | System, Phonocatheter, Intracavitary | 1 | 1 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
Most recent Cas Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190270 | FORE-SIGHT ELITE Tissue Oximeter Module | MUD | 2019-10-21 | 255 |
| K180003 | FORE-SIGHT ELITE Module Tissue Oximeter | MUD | 2018-05-10 | 128 |
| K150620 | 740 SELECT | MWI | 2015-05-08 | 59 |
| K143675 | FORE-SIGHT Elite Absolute Tissue Oximeter | MUD | 2015-04-10 | 107 |
| K140430 | 740 SELECT | MWI | 2014-06-13 | 114 |
| K133879 | FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER | MUD | 2014-04-29 | 130 |
| K130411 | 740 SELECT | MWI | 2013-05-29 | 99 |
| K123700 | FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER | MUD | 2013-04-11 | 129 |
| K112820 | FORE-SIGHT ABSOLUTE TISSUE OXIMETER | MUD | 2012-01-26 | 120 |
| K094030 | FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030 | MUD | 2010-12-23 | 358 |
22 earlier clearances. See the full list in Caduvo.
Recalls
13 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2008-09-20.
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 Cas Medical Systems, Inc.?
FDA lists 32 510(k) clearances under the applicant name “Cas Medical Systems, Inc.” (first 1985, latest 2019), across 9 product codes in 4 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 Cas Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cas Medical Systems, Inc. is 120 days.
Which FDA product codes appear under Cas Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are MUD (Oximeter, Tissue Saturation, 9); DQA (Oximeter, 6); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 6).
Next steps
- See all 32 Cas Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MUD, Cas Medical Systems, 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.