International Regulatory Consultants: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “International Regulatory Consultants” (first 1994, latest 1998), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 158 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 |
|---|---|---|---|
| FAD | Stent, Ureteral | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| LMD | System, Digital Image Communications, Radiological | 1 | 1 |
Review panels
Most recent International Regulatory Consultants 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981591 | VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT | FAD | 1998-10-09 | 158 |
| K971347 | MEDISURF | LMD | 1997-07-03 | 84 |
| K962614 | SHIFA STERILE DISPOSABLE SYRINGES | FMF | 1996-09-06 | 65 |
| K950012 | DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES | FMI | 1995-08-18 | 227 |
| K935280 | MEMOTHERM 10 BABY THERMOMETER | FLL | 1994-10-19 | 350 |
Recalls
openFDA lists no recalls under a recalling firm named International Regulatory Consultants.
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.
- International Technidyne Corp. (48 510(k)s)
- International Imaging Electronics (19 510(k)s)
- International Biomedical (17 510(k)s)
- International Biophysics Corp. (14 510(k)s)
- International Medsurg Connection (13 510(k)s)
- International Medical Products, Inc. (9 510(k)s)
- International Newtech Development, Inc. (8 510(k)s)
- International Enzymes, Inc. (7 510(k)s)
- International Medical Industries, Inc. (7 510(k)s)
- International Biomedics, Inc. (5 510(k)s)
- International Hospital Supply Co. (5 510(k)s)
- International Implant Seminars (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under International Regulatory Consultants?
FDA lists 5 510(k) clearances under the applicant name “International Regulatory Consultants” (first 1994, latest 1998), across 5 product codes in 3 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 International Regulatory Consultants?
The median time from FDA receipt to decision across 510(k)s cleared under the name International Regulatory Consultants is 158 days.
Which FDA product codes appear under International Regulatory Consultants?
The most frequent FDA product codes under this applicant name are FAD (Stent, Ureteral, 1); FLL (Continuous Measurement Thermometer, 1); FMF (Syringe, Piston, 1).
Next steps
- See all 5 International Regulatory Consultants clearances with predicates and recalls
- Run predicate analysis for product code FAD, International Regulatory Consultants'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.