Cheetah Medical, Inc.: FDA clearances and approvals
Cheetah Medical, Inc. has 7 FDA 510(k) clearances (first 2002, latest 2011), across 3 product codes in 1 review panel. Median 510(k) review time: 90 days. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
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 |
|---|---|---|---|
| DSB | Plethysmograph, Impedance | 3 | 3 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 3 | 3 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
Review panels
- Cardiovascular (7)
Most recent Cheetah Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103166 | CHEETAH RELIANT | DSB | 2011-01-25 | 90 |
| K101487 | CHEETAH NICOM SYSTEM | DXG | 2010-07-02 | 35 |
| K083093 | CHEETAH RELIANT | DSB | 2008-12-15 | 59 |
| K071631 | NICOM ELECTRODES | DXG | 2008-01-18 | 218 |
| K072662 | CHEETAH RELIANT, CHEETAH ACTIVE | DSB | 2008-01-16 | 117 |
| K042144 | NICOM | DXG | 2004-11-12 | 95 |
| K023370 | CHEETAH I.V.D.S., MODEL 2002P | DQK | 2002-12-24 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Cheetah Medical, Inc..
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.
Device clinical trials
Cheetah Medical, Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02837731: Fluid Responsiveness Evaluation in Sepsis-associated Hypotension (Completed, started 2016-10)
Frequently asked questions
How many FDA 510(k) clearances does Cheetah Medical, Inc. have?
Cheetah Medical, Inc. has 7 FDA 510(k) clearances (first 2002, latest 2011), across 3 product codes in 1 review panel.
How long does FDA take to clear Cheetah Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cheetah Medical, Inc.'s cleared 510(k)s is 90 days.
What devices does Cheetah Medical, Inc. make?
Its most frequent FDA product codes are DSB (Plethysmograph, Impedance, 3); DXG (Computer, Diagnostic, Pre-Programmed, Single-Function, 3); DQK (Computer, Diagnostic, Programmable, 1).
Has Cheetah Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cheetah Medical, Inc. Related entities may recall under other names.
Next steps
- See all 7 Cheetah Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSB, Cheetah Medical, Inc.'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.