Onset Medical Corporation: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Onset Medical Corporation” (first 2005, latest 2016), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 110 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 | 358 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 126 |
| 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | 5 | 5 |
| EZN | Dilator, Catheter, Ureteral | 2 | 2 |
| DQY | Catheter, Percutaneous | 1 | 1 |
Review panels
Most recent Onset Medical Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152498 | SoloPath Re-Collapsible Access System | DYB | 2016-01-05 | 126 |
| K121404 | SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM | DYB | 2013-05-03 | 358 |
| K112629 | ONSET ACCESS CATHETER SYSTEM | DQY | 2011-10-11 | 32 |
| K100819 | THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER | DYB | 2010-08-02 | 132 |
| K092014 | SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER | DYB | 2009-10-08 | 94 |
| K062852 | BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 | DYB | 2007-02-23 | 151 |
| K061009 | PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS | EZN | 2006-05-02 | 20 |
| K043254 | PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH | EZN | 2005-02-10 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named Onset Medical Corporation.
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 Onset Medical Corporation?
FDA lists 8 510(k) clearances under the applicant name “Onset Medical Corporation” (first 2005, latest 2016), across 3 product codes in 2 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 Onset Medical Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Onset Medical Corporation is 110 days.
Which FDA product codes appear under Onset Medical Corporation?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 5); EZN (Dilator, Catheter, Ureteral, 2); DQY (Catheter, Percutaneous, 1).
Next steps
- See all 8 Onset Medical Corporation clearances with predicates and recalls
- Run predicate analysis for product code DYB, Onset Medical Corporation'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.