Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mist, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
197 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970937 | MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM) | Mist, Inc. | 1997-09-26 | 197 | 0 |
| K971150 | MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE | Mist, Inc. | 1997-09-23 | 179 | 0 |
| K952290 | MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES, SURGICA | Mist, Inc. | 1995-06-23 | 38 | 0 |
| K952323 | MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES | Mist, Inc. | 1995-06-23 | 36 | 0 |
| K951648 | MIST ENDOSCOPIC NEEDLES | Mist, Inc. | 1995-05-12 | 32 | 0 |
| K951481 | MIST ENDOSCOPIC CANNULAS | Mist, Inc. | 1995-05-03 | 34 | 0 |
| K951480 | MIST TROCARS | Mist, Inc. | 1995-05-03 | 34 | 0 |
| K951692 | MIST ENDOSCOPIC PROBES | Mist, Inc. | 1995-05-03 | 21 | 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