Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kulzer, LLC — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
169 daysmedian FDA review time
279 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk F | Kulzer, LLC | 2026-03-11 | 1 | 0 |
| K254063 | iCEM Universal Plus | Kulzer, LLC | 2025-12-19 | 2 | 0 |
| K243910 | Retraxil | Kulzer, LLC | 2025-09-24 | 279 | 0 |
| K240660 | Signum composite flow; Signum universal bond; Signum metal b | Kulzer, LLC | 2024-09-17 | 193 | 0 |
| K233868 | dima Print Teeth & Temp | Kulzer, LLC | 2024-05-23 | 169 | 0 |
| K230644 | Signum opaque F | Kulzer, LLC | 2023-09-07 | 183 | 0 |
| K220605 | Venus Bulk Flow ONE | Kulzer, LLC | 2022-04-21 | 50 | 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