Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Leisegang Medical, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
473 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990043 | SMOOTHLASE ALEXANDRITE LASER SYSTEM | Leisegang Medical, Inc. | 1999-02-11 | 36 | 0 |
| K940094 | COLPOSCOPES AND ACCESSORIES | Leisegang Medical, Inc. | 1995-04-25 | 473 | 0 |
| K924134 | LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS | Leisegang Medical, Inc. | 1993-07-02 | 318 | 0 |
| K920217 | MAX-E-VAC | Leisegang Medical, Inc. | 1992-07-23 | 189 | 0 |
| K914201 | LM- LAP 10 HIGH FLOW INSUFFLATOR | Leisegang Medical, Inc. | 1992-01-09 | 112 | 0 |
| K912789 | LM-100/200LOW FLOW INSUFFLATOR | Leisegang Medical, Inc. | 1991-09-20 | 87 | 0 |
| K913135 | LM-300TWIN | Leisegang Medical, Inc. | 1991-09-18 | 64 | 0 |
| K911212 | LM-150HT LIGHT SOURCE | Leisegang Medical, Inc. | 1991-05-23 | 65 | 0 |
| K902313 | LM-1Z ZOOM SCOPE | Leisegang Medical, Inc. | 1990-09-04 | 104 | 0 |
| K854767 | LM 1000 | Leisegang Medical, Inc. | 1986-01-24 | 58 | 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