Regulatory & Marketing Services, Inc.: FDA clearances and approvals
Regulatory & Marketing Services, Inc. has 21 FDA 510(k) clearances (first 1993, latest 1996), across 13 product codes in 7 review panels. Median 510(k) review time: 90 days.
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 |
|---|---|---|---|
| EZL | Catheter, Retention Type, Balloon | 6 | 6 |
| FGM | Probe And Director, Gastro-Urology | 3 | 3 |
| GBX | Catheter, Irrigation | 2 | 2 |
| EZD | Catheter, Straight | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 1 | 1 |
| IQI | Orthosis, Limb Brace | 1 | 1 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 1 | 1 |
| JOH | Tube Tracheostomy And Tube Cuff | 1 | 1 |
Plus 3 more product codes.
Review panels
- Gastroenterology and Urology (13)
- General Hospital (2)
- General and Plastic Surgery (2)
- Anesthesiology (1)
- Neurology (1)
- Orthopedic (1)
- Physical Medicine (1)
Most recent Regulatory & Marketing Services, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K944673 | MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE | EZL | 1996-04-10 | 566 |
| K954752 | PEDIATRIC EUROPHYLIC FOLEY CATHETER | EZL | 1995-10-30 | 14 |
| K941342 | PAIN DOC | GZB | 1995-10-13 | 598 |
| K941543 | DIAL MEDICAL KIT | KOC | 1995-02-16 | 323 |
| K944384 | ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG | FGM | 1995-02-15 | 161 |
| K944379 | ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG | FGM | 1995-02-15 | 161 |
| K944378 | ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG | FGM | 1995-02-15 | 161 |
| K945874 | EUROMEDICAL POLY TRACHEOTOMY TUBE | JOH | 1994-12-27 | 26 |
| K944383 | ORION RED URETHRAL CATHETER | EZD | 1994-12-06 | 90 |
| K944382 | ORION ALL SILICONE FOLEY CATHETER | EZL | 1994-12-06 | 90 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Regulatory & Marketing Services, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Regulatory & Marketing Services, Inc. have?
Regulatory & Marketing Services, Inc. has 21 FDA 510(k) clearances (first 1993, latest 1996), across 13 product codes in 7 review panels.
How long does FDA take to clear Regulatory & Marketing Services, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Regulatory & Marketing Services, Inc.'s cleared 510(k)s is 90 days.
What devices does Regulatory & Marketing Services, Inc. make?
Its most frequent FDA product codes are EZL (Catheter, Retention Type, Balloon, 6); FGM (Probe And Director, Gastro-Urology, 3); GBX (Catheter, Irrigation, 2).
Has Regulatory & Marketing Services, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Regulatory & Marketing Services, Inc. Related entities may recall under other names.
Next steps
- See all 21 Regulatory & Marketing Services, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EZL, Regulatory & Marketing Services, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.