Medical Illumination International, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Medical Illumination International, Inc.” (first 2001, latest 2014), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 81 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 | 1 | 128 |
| 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 |
|---|---|---|---|
| FST | Light, Surgical, Fiberoptic | 2 | 2 |
| FSS | Light, Surgical, Floor Standing | 1 | 1 |
| FSY | Light, Surgical, Ceiling Mounted | 1 | 1 |
| LBI | Unit, Neonatal Phototherapy | 1 | 1 |
Review panels
Most recent Medical Illumination International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140812 | MI-750 PROCEDURAL/MINOR SURGICAL LIGHT | FSY | 2014-08-07 | 128 |
| K100388 | 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS | FST | 2010-06-22 | 126 |
| K053227 | LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES | FST | 2006-01-13 | 57 |
| K010495 | CENTURA PHOTOTHERAPY SPOTLIGHT | LBI | 2001-03-09 | 17 |
| K003489 | NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8 | FSS | 2001-02-02 | 81 |
Recalls
openFDA lists no recalls under a recalling firm named Medical Illumination 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.
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.
- Medical Analysis Systems, Inc. (107 510(k)s)
- Medical Components, Inc. (63 510(k)s)
- Medical Advances, Inc. (57 510(k)s)
- Medical Diagnostic Technologies, Inc. (57 510(k)s)
- Medical Devices, Inc. (49 510(k)s)
- Medical Device Technologies, Inc. (46 510(k)s)
- Medical Specialties, Inc. (40 510(k)s)
- Medical Device Inspection Co., Inc. (30 510(k)s)
- Medical Engineering Corp. (28 510(k)s)
- Medical Data Electronics (27 510(k)s)
- Medical Graphics Corp. (25 510(k)s)
- Medical Innovations Corp. (24 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Illumination International, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Medical Illumination International, Inc.” (first 2001, latest 2014), across 4 product codes in 2 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 Medical Illumination International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Illumination International, Inc. is 81 days.
Which FDA product codes appear under Medical Illumination International, Inc.?
The most frequent FDA product codes under this applicant name are FST (Light, Surgical, Fiberoptic, 2); FSS (Light, Surgical, Floor Standing, 1); FSY (Light, Surgical, Ceiling Mounted, 1).
Next steps
- See all 5 Medical Illumination International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FST, Medical Illumination 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.