Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Multigon Industries, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
652 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052067 | DOPPLER GUIDED PROCTOSCOPE, MODEL 500H | Multigon Industries, Inc. | 2005-08-29 | 28 | 0 |
| K051739 | POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, | Multigon Industries, Inc. | 2005-07-28 | 30 | 0 |
| K912044 | MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR | Multigon Industries, Inc. | 1991-06-24 | 47 | 0 |
| K881263 | MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER | Multigon Industries, Inc. | 1990-01-05 | 652 | 0 |
| K882755 | MODEL 500V VASCULAR SPECTRUM ANALYZER | Multigon Industries, Inc. | 1988-11-29 | 147 | 0 |
| K863589 | MODEL 600 VASCULAR DUPLEX IMAGER | Multigon Industries, Inc. | 1987-06-24 | 282 | 0 |
| K860435 | MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER | Multigon Industries, Inc. | 1986-05-05 | 90 | 0 |
| K852680 | TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG | Multigon Industries, Inc. | 1985-12-23 | 181 | 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