Syncor Intl. Corp.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Syncor Intl. Corp.” (first 1983, latest 1995), across 21 product codes in 5 review panels. Median 510(k) review time under this name: 68 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 | 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 4 | 4 |
| KXK | Source, Brachytherapy, Radionuclide | 3 | 3 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 2 | 2 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 2 | 2 |
| CKG | Radioimmunoassay, Acth | 2 | 2 |
| IWA | Source, Wire, Iridium, Radioactive | 2 | 2 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 1 | 1 |
Plus 11 more product codes.
Review panels
- Clinical Chemistry (16)
- Radiology (9)
- Microbiology (3)
- Ear, Nose and Throat (1)
- General Hospital (1)
Most recent Syncor Intl. Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945825 | SECURE SAFETY INSERT | FMI | 1995-04-10 | 132 |
| K851828 | IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C | MOT | 1985-09-19 | 146 |
| K852023 | CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 | KXK | 1985-08-21 | 105 |
| K850433 | CESIUM 137 ENDOMETRIAL SOURCE | KXK | 1985-08-21 | 198 |
| K852665 | SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY | JWZ | 1985-08-13 | 50 |
| K851033 | SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT | LJP | 1985-06-21 | 101 |
| K844735 | PTH-RIA | CEW | 1985-04-29 | 146 |
| K850726 | WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD | IWA | 1985-03-26 | 32 |
| K850434 | CS137 SEALED SOURCES | KXK | 1985-03-26 | 50 |
| K850208 | FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS | IXD | 1985-03-26 | 67 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Syncor Intl. Corp..
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.
- Syncor Pharmaceuticals, Inc. (4 510(k)s)
- Syncor International, Inc. (2 510(k)s)
- Syncor Radiation Management (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Syncor Intl. Corp.?
FDA lists 31 510(k) clearances under the applicant name “Syncor Intl. Corp.” (first 1983, latest 1995), across 21 product codes in 5 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 Syncor Intl. Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Syncor Intl. Corp. is 68 days.
Which FDA product codes appear under Syncor Intl. Corp.?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 4); KXK (Source, Brachytherapy, Radionuclide, 3); CEP (Radioimmunoassay, Luteinizing Hormone, 2).
Next steps
- See all 31 Syncor Intl. Corp. clearances with predicates and recalls
- Run predicate analysis for product code JHI, Syncor Intl. Corp.'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.