Sorensen Research: FDA filings under this applicant name
FDA lists 69 510(k) clearances under the applicant name “Sorensen Research” (first 1976, latest 1984), across 21 product codes in 5 review panels. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | 22 | 22 |
| CAC | Apparatus, Autotransfusion | 7 | 7 |
| DRS | Transducer, Blood-Pressure, Extravascular | 7 | 7 |
| FIE | Needle, Fistula | 6 | 6 |
| DYB | Introducer, Catheter | 4 | 4 |
| FJT | Intracatheter, Dialysis | 3 | 3 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 3 | 3 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | 2 | 2 |
| DYG | Catheter, Flow Directed | 2 | 2 |
| KDP | Regulator, Vacuum | 2 | 2 |
Plus 11 more product codes.
Review panels
- Gastroenterology and Urology (34)
- Cardiovascular (25)
- General Hospital (7)
- Physical Medicine (1)
- General and Plastic Surgery (1)
Most recent Sorensen Research 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K833674 | ACCURATE MEASUREMENT DEVICE KG-AMD | GCX | 1984-01-25 | 99 |
| K833673 | ACCURATE MEASUREMENT DEVICE EZ-AMD | GCX | 1983-12-29 | 72 |
| K833096 | TRANSDUCER DOME DS106 | DRS | 1983-11-03 | 52 |
| K833095 | TRANSDUCER DOME SD105 | DRS | 1983-11-03 | 52 |
| K833094 | TRANSDUCER DOME SD104 | DRS | 1983-11-03 | 52 |
| K832957 | FLOW-DIRECTED HEPARIN COATED THERMODIL | DYG | 1983-09-29 | 29 |
| K831506 | DISP. TRANSDUCER W/MONITORING KIT TRANS | DRS | 1983-08-12 | 93 |
| K831939 | TALL FLOOR STAND TFS-01 | GCX | 1983-07-19 | 33 |
| K831505 | THORACIC GAUGE #TG-60 -VACUUM REGULATOR | KDP | 1983-07-12 | 62 |
| K820706 | WATERLESS SEAL & VACUUM REGULATOR | KDP | 1982-04-09 | 24 |
59 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sorensen Research.
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 Sorensen Research?
FDA lists 69 510(k) clearances under the applicant name “Sorensen Research” (first 1976, latest 1984), 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 Sorensen Research?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sorensen Research is 32 days.
Which FDA product codes appear under Sorensen Research?
The most frequent FDA product codes under this applicant name are KOC (Accessories, Blood Circuit, Hemodialysis, 22); CAC (Apparatus, Autotransfusion, 7); DRS (Transducer, Blood-Pressure, Extravascular, 7).
Next steps
- See all 69 Sorensen Research clearances with predicates and recalls
- Run predicate analysis for product code KOC, Sorensen Research'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.