Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mahe-Medizintechnik · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
237 daysmedian FDA review time
333 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942821 | MAHE INSTRUMENTS | Mahe-Medizintechnik | 1994-11-02 | 141 | 0 |
| K942819 | TROCAR WITH SHIELD | Mahe-Medizintechnik | 1994-08-23 | 70 | 0 |
| K933768 | COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES | Mahe-Medizintechnik | 1994-06-27 | 333 | 0 |
| K933767 | FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY | Mahe-Medizintechnik | 1994-05-26 | 301 | 0 |
| K933770 | FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE | Mahe-Medizintechnik | 1994-03-23 | 237 | 0 |
| K935442 | MAHE INSTRUMENTS | Mahe-Medizintechnik | 1994-03-14 | 122 | 0 |
| K933772 | PUNCH SURGICAL | Mahe-Medizintechnik | 1994-02-01 | 187 | 0 |
| K925624 | MICROSURGICAL INSTRUMENTS | Mahe-Medizintechnik | 1993-07-22 | 258 | 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