Cedars-Sinai Medical Center: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Cedars-Sinai Medical Center” (first 2011, latest 2017), across 1 product code in 1 review panel. Median 510(k) review time under this name: 64 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 | 1 | 111 |
| 2014 | 1 | 32 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 64 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 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 Cedars-Sinai Medical Center took a median 64 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 63 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | 5 | 5 |
Review panels
- Radiology (5)
Most recent Cedars-Sinai Medical Center 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172609 | CSMC Cardiac Suite | KPS | 2017-11-03 | 64 |
| K141652 | CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE | KPS | 2014-07-22 | 32 |
| K123433 | CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE | KPS | 2013-02-26 | 111 |
| K112474 | CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE | KPS | 2011-09-23 | 28 |
| K100714 | CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01 | KPS | 2011-04-01 | 385 |
Recalls
openFDA lists no recalls under a recalling firm named Cedars-Sinai Medical Center.
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.
- Cedars-Sinai Medical Center: Aim (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cedars-Sinai Medical Center?
FDA lists 5 510(k) clearances under the applicant name “Cedars-Sinai Medical Center” (first 2011, latest 2017), across 1 product code 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 Cedars-Sinai Medical Center?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cedars-Sinai Medical Center is 64 days.
Which FDA product codes appear under Cedars-Sinai Medical Center?
The most frequent FDA product codes under this applicant name are KPS (System, Tomography, Computed, Emission, 5).
Next steps
- See all 5 Cedars-Sinai Medical Center clearances with predicates and recalls
- Run predicate analysis for product code KPS, Cedars-Sinai Medical Center'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.