Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Invotec International, Inc. · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
289 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122040 | INVOTEC LARYNGEAL ELECTRODE | Invotec International, Inc. | 2013-10-31 | 476 | 0 |
| K080740 | CLEARVIEW ENDOSCOPE COVER | Invotec International, Inc. | 2008-12-31 | 289 | 0 |
| K030492 | TITANIUM OSSICULAR REPLACMENT SYSTEM | Invotec International, Inc. | 2003-03-03 | 12 | 0 |
| K973580 | INVOTEC CLEAN PAD | Invotec International, Inc. | 1997-12-10 | 82 | 0 |
| K973578 | INVOTEC EAR TAMPON (WICK) W/STRING | Invotec International, Inc. | 1997-11-06 | 48 | 0 |
| K971000 | EPISTAXIS NASAL PACK | Invotec International, Inc. | 1997-05-14 | 56 | 0 |
| K930114 | TRACHEOSTOMY T-TUBE | Invotec International, Inc. | 1993-03-19 | 67 | 0 |
| K911041 | INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE | Invotec International, Inc. | 1991-06-04 | 88 | 0 |
| K911040 | INVOTEC MICROSCOPE DRAPE | Invotec International, Inc. | 1991-06-03 | 87 | 0 |
| K911039 | INVOTEC EAR DRAPE | Invotec International, Inc. | 1991-05-13 | 66 | 0 |
| K901923 | INVOTEC POLY-MESH MANDIBULAR TRAY | Invotec International, Inc. | 1990-10-31 | 184 | 0 |
| K903285 | MICRO BRIGHT VENTILATION TUBES | Invotec International, Inc. | 1990-09-26 | 64 | 0 |
| K901306 | INVOTEC BI-VALVE SPLINT | Invotec International, Inc. | 1990-06-14 | 86 | 0 |
| K901307 | PASSAGE AIRWAY SPLINT | Invotec International, Inc. | 1990-06-14 | 86 | 0 |
| K901310 | ULTRASTAT NASAL CATHETER | Invotec International, Inc. | 1990-06-14 | 86 | 0 |
| K901366 | INVOTEC SEPTAL BUTTON | Invotec International, Inc. | 1990-06-14 | 83 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda