Mauna Kea Technologies: FDA filings under this applicant name
FDA lists 19 510(k) clearances under 2 spellings of the applicant name “Mauna Kea Technologies” (first 2005, latest 2022), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 88 days. Since 2017 the median was 84 days, against 93 days for all cleared 510(k)s in the same product codes. 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 | 2 | 70 |
| 2013 | 1 | 139 |
| 2014 | 2 | 190 |
| 2015 | 2 | 200 |
| 2016 | 1 | 94 |
| 2017 | 2 | 88 |
| 2018 | 1 | 111 |
| 2019 | 1 | 58 |
| 2020 | 2 | 175 |
| 2021 | 1 | 23 |
| 2022 | 1 | 52 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mauna Kea Technologies took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 93 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OWN | Confocal Optical Imaging | 16 | 16 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| GWG | Endoscope, Neurological | 1 | 1 |
Review panels
- General and Plastic Surgery (18)
- Neurology (1)
Most recent Mauna Kea Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220477 | Cellvizio 100 series system with confocal Miniprobes | OWN | 2022-04-11 | 52 |
| K212322 | Cellvizio I.V.E. system with Confocal Miniprobes | OWN | 2021-08-18 | 23 |
| K193416 | Cellvizio I.V.E. with Confocal Miniprobes | OWN | 2020-02-28 | 81 |
| K191144 | Cellvizio 100 Series System with Confocal Miniprobes | OWN | 2020-01-24 | 269 |
| K183640 | Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes | OWN | 2019-02-22 | 58 |
| K180270 | Cellvizio 100 Series Systems with Confocal Miniprobes | GWG | 2018-05-22 | 111 |
| K172844 | Cellvizio 100 Series System with Confocal Miniprobes | OWN | 2017-12-15 | 87 |
| K171345 | Cellvizio 100 Series Systems with Confocal Miniprobes | OWN | 2017-08-04 | 88 |
| K160416 | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes | OWN | 2016-05-20 | 94 |
| K150831 | Cellvizio 100 Series System with Confocal Miniprobes | OWN | 2015-12-22 | 267 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mauna Kea Technologies.
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.
Device clinical trials
An industry sponsor named Mauna Kea Technologies is the lead sponsor of 8 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02288104: Needle-based Confocal Laser Endomicroscopy in CT-guided Percutaneous Procedures (Completed, started 2015-01)
- NCT02224885: Needle-based Confocal Laser Endomicroscopy in Fluoroscopy-guided Procedures (Completed, started 2015-01)
- NCT02221076: Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Procedures. (Completed, started 2014-07)
- NCT01770405: Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract (Completed, started 2013-09)
- NCT01793246: Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy in the Lung (Completed, started 2013-02)
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Mauna Kea Technologies (18)
- Mauna Kea Technologies, Inc. (1)
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.
- Mauna Loa Medical, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mauna Kea Technologies?
FDA lists 19 510(k) clearances under 2 spellings of the applicant name “Mauna Kea Technologies” (first 2005, latest 2022), across 3 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 Mauna Kea Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mauna Kea Technologies is 88 days. Since 2017: 84 days, versus 93 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Mauna Kea Technologies?
The most frequent FDA product codes under this applicant name are OWN (Confocal Optical Imaging, 16); GCJ (Laparoscope, General & Plastic Surgery, 2); GWG (Endoscope, Neurological, 1).
Next steps
- See all 19 Mauna Kea Technologies clearances with predicates and recalls
- Run predicate analysis for product code OWN, Mauna Kea Technologies'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.