Syntermed, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Syntermed, Inc.” (first 2000, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 80 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 | 3 | 84 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 218 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 136 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Syntermed, Inc. took a median 177 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 117 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | 13 | 13 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Radiology (14)
Most recent Syntermed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223422 | Emory Cardiac Toolbox 4.3 | KPS | 2023-03-30 | 136 |
| K180077 | NeuroQ 3.8 | KPS | 2018-08-16 | 218 |
| K130902 | EMORY CARDIAC TOOLBOX 3.2 | KPS | 2013-06-14 | 74 |
| K130451 | NEUROQ 3.6 | KPS | 2013-05-17 | 84 |
| K123646 | EMORY CARDIAC TOOLBOX 4.0 | KPS | 2013-02-22 | 87 |
| K072307 | QUANTITATIVE NEUROQ 3.0 | KPS | 2008-03-14 | 210 |
| K071503 | SYSTEM, TOMOGRAPHY, COMPUTED EMISSION | KPS | 2007-07-26 | 55 |
| K070089 | SYNTERMED LIVE | LLZ | 2007-03-02 | 52 |
| K042258 | BP-SPECT V1.O | KPS | 2004-10-04 | 45 |
| K041022 | NEUROQ - PET DP | KPS | 2004-06-17 | 58 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Syntermed, Inc..
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 Syntermed, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Syntermed, Inc.” (first 2000, latest 2023), 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 Syntermed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Syntermed, Inc. is 80 days.
Which FDA product codes appear under Syntermed, Inc.?
The most frequent FDA product codes under this applicant name are KPS (System, Tomography, Computed, Emission, 13); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 14 Syntermed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KPS, Syntermed, 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.