Mist, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Mist, Inc.” (first 1995, latest 1997), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 35 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 5 | 5 |
| JOS | Electrode, Electrosurgical | 2 | 2 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
Review panels
Most recent Mist, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970937 | MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM) | GCJ | 1997-09-26 | 197 |
| K971150 | MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE | GCJ | 1997-09-23 | 179 |
| K952323 | MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES | JOS | 1995-06-23 | 36 |
| K952290 | MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES, SURGICAL INSTRUMENTS USED DURING ENDOSCOPIC PROCEDURES | JOS | 1995-06-23 | 38 |
| K951648 | MIST ENDOSCOPIC NEEDLES | FBK | 1995-05-12 | 32 |
| K951692 | MIST ENDOSCOPIC PROBES | GCJ | 1995-05-03 | 21 |
| K951481 | MIST ENDOSCOPIC CANNULAS | GCJ | 1995-05-03 | 34 |
| K951480 | MIST TROCARS | GCJ | 1995-05-03 | 34 |
Recalls
openFDA lists no recalls under a recalling firm named Mist, 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 Mist, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Mist, Inc.” (first 1995, latest 1997), 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 Mist, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mist, Inc. is 35 days.
Which FDA product codes appear under Mist, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 5); JOS (Electrode, Electrosurgical, 2); FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 1).
Next steps
- See all 8 Mist, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Mist, 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.