Rochester Medical Corp.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Rochester Medical Corp.” (first 1990, latest 2013), plus 1 PMA decision, across 7 product codes in 1 review panel. Median 510(k) review time under this name: 117 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 | 245 |
| 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 |
|---|---|---|---|
| EZL | Catheter, Retention Type, Balloon | 3 | 3 |
| MJC | Catheter, Urological (Antimicrobial) And Accessories | 3 | 3 |
| EXJ | Device, Incontinence, Urosheath Type, Sterile | 2 | 2 |
| GBM | Catheter, Urethral | 2 | 2 |
| KOD | Catheter, Urological | 2 | 2 |
| EZD | Catheter, Straight | 1 | 1 |
| OCK | Transurethral Occlusion Insert, Urinary Incontinence-Control, Female | 1 | 0 |
Review panels
Most recent Rochester Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122785 | HYDROSIL; MAGIC; PERSONAL CATHETER | EZD | 2013-05-14 | 245 |
| K033477 | HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT | MJC | 2004-06-10 | 220 |
| K001143 | RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER | MJC | 2000-07-07 | 88 |
| K000723 | HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) | KOD | 2000-05-19 | 74 |
| K981612 | ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER | EZL | 1998-07-08 | 63 |
| K971627 | SILICONE ANTIBACTERIAL FOLEY CATHETER | MJC | 1998-01-13 | 256 |
| K970704 | PERSONAL CATHETER | GBM | 1997-03-13 | 15 |
| K952082 | ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER | EXJ | 1995-07-18 | 76 |
| K941692 | FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER | EZL | 1995-03-06 | 334 |
| K943851 | ALL SILICONE INTERMITTENT CATHETER | GBM | 1995-01-31 | 176 |
3 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P990002 | PMA | FEMSOFT URETHRAL INSERT | 1999-09-30 |
Recalls
22 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2010-04-27.
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.
- Rochester Electro Medical, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rochester Medical Corp.?
FDA lists 13 510(k) clearances under the applicant name “Rochester Medical Corp.” (first 1990, latest 2013), plus 1 PMA decision, across 7 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 Rochester Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rochester Medical Corp. is 117 days.
Which FDA product codes appear under Rochester Medical Corp.?
The most frequent FDA product codes under this applicant name are EZL (Catheter, Retention Type, Balloon, 3); MJC (Catheter, Urological (Antimicrobial) And Accessories, 3); EXJ (Device, Incontinence, Urosheath Type, Sterile, 2).
Next steps
- See all 13 Rochester Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code EZL, Rochester Medical 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.