Sorenson Medical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Sorenson Medical, Inc.” (first 1999, latest 2005), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 22 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 |
|---|---|---|---|
| FRN | Pump, Infusion | 4 | 4 |
| KPE | Container, I.V. | 1 | 1 |
| MEA | Pump, Infusion, Pca | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Sorenson Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K052221 | AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP | FRN | 2005-12-08 | 115 |
| K033425 | AMBIT INTERMITTENT AMBULATORY INFUSION PUMP | FRN | 2003-11-06 | 10 |
| K033325 | AMBIT CONTINUOUS AMBULATORY INFUSION PUMP | FRN | 2003-11-06 | 21 |
| K002434 | PALM PUMP | MEA | 2000-08-23 | 14 |
| K001287 | EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML | KPE | 2000-06-09 | 46 |
| K991363 | 30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU | FRN | 1999-05-13 | 23 |
Recalls
6 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2006-10-10.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Sorenson Medical, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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.
- Sorenson Laboratories, Inc. (3 510(k)s)
- Sorenson Critical Care (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sorenson Medical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Sorenson Medical, Inc.” (first 1999, latest 2005), across 3 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 Sorenson Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sorenson Medical, Inc. is 22 days.
Which FDA product codes appear under Sorenson Medical, Inc.?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 4); KPE (Container, I.V., 1); MEA (Pump, Infusion, Pca, 1).
Next steps
- See all 6 Sorenson Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Sorenson Medical, 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.