Inmed Corp.: FDA filings under this applicant name
FDA lists 32 510(k) clearances under the applicant name “Inmed Corp.” (first 1981, latest 1986), across 15 product codes in 4 review panels. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 11 | 11 |
| KOD | Catheter, Urological | 5 | 5 |
| BTQ | Airway, Nasopharyngeal | 2 | 2 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 1 | 1 |
| BZW | Stethoscope, Esophageal | 1 | 1 |
| EMX | Balloon, Epistaxis | 1 | 1 |
| FWZ | Operating Room Accessories Table Tray | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
Plus 5 more product codes.
Review panels
- Gastroenterology and Urology (20)
- Anesthesiology (7)
- General and Plastic Surgery (2)
- Ear, Nose and Throat (1)
Most recent Inmed Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K862672 | ESOPHAGEAL STETHOSCOPE WITH THERMISTOR | BZT | 1986-10-27 | 105 |
| K853162 | STERILE NASOPHARYNGEAL AIRWAY | BTQ | 1985-08-06 | 7 |
| K850335 | URETEROSCOPY CATHETER | KOD | 1985-03-12 | 43 |
| K850248 | DISPOSABLE GUEDEL AIRWAY | CAE | 1985-03-12 | 49 |
| K850152 | PRECONNECTED URETHRAL CATHETER TRAY | — | 1985-03-12 | 56 |
| K844801 | ULTRA EXTERNAL CATHETER | KNX | 1985-01-15 | 35 |
| K842301 | DISPOSABLE LATEX BANDAGE | KGX | 1984-11-05 | 147 |
| K842866 | URETHRAL CATHETERIZATION TRAY | KOD | 1984-09-10 | 49 |
| K841040 | FOX POST NASAL BALLOON CATHETER | EMX | 1984-08-17 | 158 |
| K842865 | ESOPHAGEAL STETHOSCOPE | BZW | 1984-08-15 | 23 |
22 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Inmed Corp..
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.
- Inmed Ltda. (3 510(k)s)
- Inmed Gloves Factory (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Inmed Corp.?
FDA lists 32 510(k) clearances under the applicant name “Inmed Corp.” (first 1981, latest 1986), across 15 product codes in 4 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 Inmed Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Inmed Corp. is 36 days.
Which FDA product codes appear under Inmed Corp.?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 11); KOD (Catheter, Urological, 5); BTQ (Airway, Nasopharyngeal, 2).
Next steps
- See all 32 Inmed Corp. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Inmed 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.