Telemed Systems, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Telemed Systems, Inc.” (first 1990, latest 2002), across 16 product codes in 4 review panels. Median 510(k) review time under this name: 86 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 5 | 5 |
| FDX | Endoscopic Cytology Brush | 2 | 2 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 2 | 2 |
| FAT | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | 1 | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FDI | Snare, Flexible | 1 | 1 |
| FEB | Accessories, Cleaning, For Endoscope | 1 | 1 |
| FFP | Dilator, Rectal | 1 | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
| KGE | Forceps, Biopsy, Electric | 1 | 1 |
Plus 6 more product codes.
Review panels
Most recent Telemed Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020379 | PPD BALLOON DILATATION CATHETER | KNT | 2002-05-06 | 90 |
| K013737 | MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON | FGE | 2002-03-01 | 108 |
| K010412 | FLEXIBLE ENDOSCOPIC SCISSORS | OCZ | 2001-04-02 | 49 |
| K992402 | 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH | KNS | 1999-12-22 | 156 |
| K992390 | HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD | KGE | 1999-12-22 | 156 |
| K974312 | REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR | KNW | 1998-01-21 | 65 |
| K974300 | TELEMED SYSTEMS RETRIEVAL BASKET | OCZ | 1997-12-19 | 32 |
| K901435 | GASTROINTESTINAL CYTOLOGY BRUSH | FDX | 1990-07-16 | 112 |
| K901427 | BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON | FGE | 1990-06-22 | 88 |
| K901433 | SURE-FLEX ANASTOMOTIC BALLOON DILATOR | FGE | 1990-06-21 | 87 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Telemed Systems, 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.
- Telemed (5 510(k)s)
- Telemed Div. (2 510(k)s)
- Telemed Solutions, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Telemed Systems, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Telemed Systems, Inc.” (first 1990, latest 2002), across 16 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 Telemed Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Telemed Systems, Inc. is 86 days.
Which FDA product codes appear under Telemed Systems, Inc.?
The most frequent FDA product codes under this applicant name are FGE (Stents, Drains And Dilators For The Biliary Ducts, 5); FDX (Endoscopic Cytology Brush, 2); OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered, 2).
Next steps
- See all 22 Telemed Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FGE, Telemed Systems, 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 (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.