Intermed, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Intermed, Inc.” (first 1976, latest 1990), across 12 product codes in 6 review panels. Median 510(k) review time under this name: 76 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 |
|---|---|---|---|
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 3 | 3 |
| KOD | Catheter, Urological | 3 | 3 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| EQN | Laryngoscope, Nasopharyngoscope | 1 | 1 |
| EYN | Tray, Irrigation, Sterile | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| GBZ | Catheter, Cholangiography | 1 | 1 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 1 | 1 |
Plus 2 more product codes.
Review panels
- Gastroenterology and Urology (8)
- Cardiovascular (2)
- General and Plastic Surgery (2)
- Anesthesiology (1)
- Ear, Nose and Throat (1)
- General Hospital (1)
Most recent Intermed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K900857 | NON STERILE PARENTERAL SUPPLY KIT | FMF | 1990-05-22 | 88 |
| K842166 | INTERMED, INS STERILE WATER/SALINE | BSY | 1985-02-12 | 257 |
| K833126 | DRESSING CHANGE TRAYS | — | 1984-01-27 | 136 |
| K833574 | PERCUTANEOUS SHEATH INTRODUCER TRAYS | DQX | 1984-01-11 | 91 |
| K833573 | CENTRAL VEIN CATH. TRAY CC-20-1420 | DQY | 1984-01-11 | 91 |
| K833139 | ACUTE HEMODIALYSIS TRAYS | KNZ | 1983-12-22 | 99 |
| K833059 | SUCTION CATHETER TRAYS | GBZ | 1983-12-12 | 95 |
| K821269 | TRACHEOSTOMY CARE TRAYS | EQN | 1982-05-27 | 24 |
| K791427 | CATHETERIZATION TRAYS FOLEY AND URETHRAL | KOD | 1979-09-07 | 43 |
| K791426 | PERITONEAL PAC | KDJ | 1979-08-28 | 33 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Intermed, 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.
- Intermed Advisors, Inc. (1 510(k)s)
- Intermed Group, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intermed, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Intermed, Inc.” (first 1976, latest 1990), across 12 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 Intermed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intermed, Inc. is 76 days.
Which FDA product codes appear under Intermed, Inc.?
The most frequent FDA product codes under this applicant name are KNX (Collector, Urine, (And Accessories) For Indwelling Catheter, 3); KOD (Catheter, Urological, 3); BSY (Catheters, Suction, Tracheobronchial, 1).
Next steps
- See all 16 Intermed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNX, Intermed, 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.