Intl. Medical, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Intl. Medical, Inc.” (first 1979, latest 1997), across 15 product codes in 6 review panels. Median 510(k) review time under this name: 108 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| BZH | Meter, Peak Flow, Spirometry | 1 | 1 |
| DPS | Electrocardiograph | 1 | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DSB | Plethysmograph, Impedance | 1 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| FCF | Instrument, Biopsy, Mechanical, Gastrointestinal | 1 | 1 |
| FDI | Snare, Flexible | 1 | 1 |
| FDX | Endoscopic Cytology Brush | 1 | 1 |
Plus 5 more product codes.
Review panels
- Gastroenterology and Urology (6)
- Cardiovascular (4)
- General Hospital (2)
- Obstetrics and Gynecology (2)
- General and Plastic Surgery (2)
- Anesthesiology (1)
Most recent Intl. Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970507 | PEAK FLOW METER | BZH | 1997-06-13 | 123 |
| K943078 | HOT BIOPSY FORCEPS | KGE | 1994-11-14 | 139 |
| K940370 | AMERICAN CATHETER E.R.C.P. CANNULA | FGE | 1994-08-17 | 203 |
| K940335 | AMERICAN CATHETER POLY-SNARE | FDI | 1994-07-21 | 177 |
| K942068 | AMERICAN CATHETER SPHINCTEROTOME | KNS | 1994-06-24 | 56 |
| K930410 | DURHAM; LUER LOCK EXTENSION SET | FPA | 1993-09-03 | 220 |
| K930406 | DURHAM; MIN BORE LUER LOCK EXTENSION SET | FPA | 1993-09-03 | 220 |
| K923200 | AMCATH DISPOSABLE CYTOLOGY BRUSH | FDX | 1992-12-07 | 160 |
| K915142 | AMCATH DISPOSABLE BIOPSY FORCEPS | FCF | 1992-01-10 | 57 |
| K912927 | AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE | GCJ | 1991-09-19 | 78 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Intl. Medical, Inc..
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.
- Intl. Diagnostic Technology (29 510(k)s)
- Intl. Immunoassay Laboratories, Inc. (27 510(k)s)
- Intl. Remote Imaging Systems (14 510(k)s)
- Intl. Medical Devices , Ltd. (12 510(k)s)
- Intl. Playtex, Inc. (10 510(k)s)
- Intl. Business Machines (8 510(k)s)
- Intl. Bioclinical, Inc. (6 510(k)s)
- Intl. Diagnostic, Inc. (6 510(k)s)
- Intl. Medical Consultants (6 510(k)s)
- Intl. Medical Equipment Corp. (6 510(k)s)
- Intl. Ophthalmic Industries Corp. (6 510(k)s)
- Intl. Trade Management Co. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intl. Medical, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Intl. Medical, Inc.” (first 1979, latest 1997), across 15 product codes in 6 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 Intl. Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intl. Medical, Inc. is 108 days.
Which FDA product codes appear under Intl. Medical, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 2); GCJ (Laparoscope, General & Plastic Surgery, 2); BZH (Meter, Peak Flow, Spirometry, 1).
Next steps
- See all 17 Intl. Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Intl. Medical, 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.