Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kretztechnik AG — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
259 daysmedian FDA review time
766 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925354 | COMBISON(R) 311 | Kretztechnik AG | 1993-07-08 | 259 | 0 |
| K904070 | COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A | Kretztechnik AG | 1992-10-09 | 766 | 0 |
| K910966 | SECTOR TRANSDUCER MODEL NO. AWP3.5/A | Kretztechnik AG | 1992-04-17 | 408 | 0 |
| K904665 | MODEL IW17.5A INTRA OPERATIVE TRANSDUCER | Kretztechnik AG | 1991-01-11 | 88 | 0 |
| K901725 | ADD'L TRANSDUCER FOR USE W/THE COMBISON 310A | Kretztechnik AG | 1990-08-15 | 121 | 0 |
| K901655 | 1 TRANSDUCER FOR COMBISON 310A | Kretztechnik AG | 1990-07-20 | 102 | 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