Invotec International, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Invotec International, Inc.” (first 1990, latest 2013), across 14 product codes in 5 review panels. Median 510(k) review time under this name: 84 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 | 1 | 476 |
| 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 |
|---|---|---|---|
| EMX | Balloon, Epistaxis | 2 | 2 |
| LYA | Splint, Intranasal Septal | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| ETA | Replacement, Ossicular Prosthesis, Total | 1 | 1 |
| ETD | Tube, Tympanostomy | 1 | 1 |
| ETN | Stimulator, Nerve | 1 | 1 |
| HMW | Drape, Microscope, Ophthalmic | 1 | 1 |
| IXA | Cassette, Radiographic Film | 1 | 1 |
Plus 4 more product codes.
Review panels
- Ear, Nose and Throat (11)
- General Hospital (2)
- Anesthesiology (1)
- Radiology (1)
- General and Plastic Surgery (1)
Most recent Invotec International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122040 | INVOTEC LARYNGEAL ELECTRODE | ETN | 2013-10-31 | 476 |
| K080740 | CLEARVIEW ENDOSCOPE COVER | EOB | 2008-12-31 | 289 |
| K030492 | TITANIUM OSSICULAR REPLACMENT SYSTEM | ETA | 2003-03-03 | 12 |
| K973580 | INVOTEC CLEAN PAD | EFQ | 1997-12-10 | 82 |
| K973578 | INVOTEC EAR TAMPON (WICK) W/STRING | KCN | 1997-11-06 | 48 |
| K971000 | EPISTAXIS NASAL PACK | EMX | 1997-05-14 | 56 |
| K930114 | TRACHEOSTOMY T-TUBE | BTR | 1993-03-19 | 67 |
| K911041 | INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE | IXA | 1991-06-04 | 88 |
| K911040 | INVOTEC MICROSCOPE DRAPE | HMW | 1991-06-03 | 87 |
| K911039 | INVOTEC EAR DRAPE | KKX | 1991-05-13 | 66 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Invotec International, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Invotec International, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Invotec International, Inc.” (first 1990, latest 2013), across 14 product codes in 5 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 Invotec International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Invotec International, Inc. is 84 days.
Which FDA product codes appear under Invotec International, Inc.?
The most frequent FDA product codes under this applicant name are EMX (Balloon, Epistaxis, 2); LYA (Splint, Intranasal Septal, 2); BTR (Tube, Tracheal (W/Wo Connector), 1).
Next steps
- See all 16 Invotec International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EMX, Invotec International, 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.