International Medical Industries, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “International Medical Industries, Inc.” (first 2017, latest 2024), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 199 days. Since 2017 the median was 199 days, against 189 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2017 | 1 | 214 |
| 2018 | 1 | 199 |
| 2019 | 2 | 96 |
| 2020 | 2 | 156 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 505 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name International Medical Industries, Inc. took a median 199 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 189 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMF | Syringe, Piston | 2 | 2 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| KPE | Container, I.V. | 1 | 1 |
| LHI | Set, I.V. Fluid Transfer | 1 | 1 |
| PNR | Enteral Syringes With Enteral Specific Connectors | 1 | 1 |
| QEH | Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact | 1 | 1 |
Review panels
Most recent International Medical Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231095 | Tamper Evident Cap | FMF | 2024-09-04 | 505 |
| K201031 | NRFit® Caps, Male and Female Neuraxial Tip Caps | QEH | 2020-12-16 | 240 |
| K193192 | Tamper Evident Cap | FMF | 2020-01-31 | 73 |
| K190305 | Additive Cap | KPE | 2019-04-30 | 77 |
| K182545 | Tamper Evident Cap with Male Luer Lock | FPA | 2019-01-11 | 116 |
| K173577 | Guarded Luer Connector | LHI | 2018-06-07 | 199 |
| K170672 | Tamper Evident Cap For use with ENFit Syringes | PNR | 2017-10-06 | 214 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-09-16.
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 Biomedics, Inc. (5 510(k)s)
- International Hospital Supply Co. (5 510(k)s)
- International Regulatory Consultants (5 510(k)s)
- International Implant Seminars (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under International Medical Industries, Inc.?
FDA lists 7 510(k) clearances under the applicant name “International Medical Industries, Inc.” (first 2017, latest 2024), across 6 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 International Medical Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name International Medical Industries, Inc. is 199 days. Since 2017: 199 days, versus 189 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under International Medical Industries, Inc.?
The most frequent FDA product codes under this applicant name are FMF (Syringe, Piston, 2); FPA (Set, Administration, Intravascular, 1); KPE (Container, I.V., 1).
Next steps
- See all 7 International Medical Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMF, International Medical Industries, 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.