Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bauer, Cheng & Associates, Inc. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
26 daysmedian FDA review time
66 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K840084 | COLTENE BRILLIANT LUX | Bauer, Cheng & Associates, Inc. | 1984-03-30 | 80 | 0 |
| K840085 | COLTENE BRILLIANT | Bauer, Cheng & Associates, Inc. | 1984-03-16 | 66 | 0 |
| K823084 | CHALLENGER | Bauer, Cheng & Associates, Inc. | 1982-11-10 | 22 | 0 |
| K823099 | RX MIDACAST | Bauer, Cheng & Associates, Inc. | 1982-11-10 | 22 | 0 |
| K823097 | NATURELLE | Bauer, Cheng & Associates, Inc. | 1982-11-10 | 22 | 0 |
| K823098 | REX-CAPS | Bauer, Cheng & Associates, Inc. | 1982-11-10 | 22 | 0 |
| K823100 | RX 91 | Bauer, Cheng & Associates, Inc. | 1982-11-10 | 22 | 0 |
| K810972 | THE GNATHOMETER-M | Bauer, Cheng & Associates, Inc. | 1981-05-05 | 26 | 0 |
| K810971 | THE GNATOMET | Bauer, Cheng & Associates, Inc. | 1981-05-05 | 26 | 0 |
| K810970 | ISOSIT TEETH | Bauer, Cheng & Associates, Inc. | 1981-05-05 | 26 | 0 |
| K810969 | ISOSIT C & B MATERIAL | Bauer, Cheng & Associates, Inc. | 1981-05-05 | 26 | 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