Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KXZ — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
104 daysmedian FDA review time
198 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K851034 | NOVATHERM | Medtech Products, Inc. | 1985-09-27 | 198 | 0 |
| K843124 | Q-SCAN THERMOGRAPHY SYSTEM | Qmax Medical, Inc. | 1984-11-29 | 113 | 0 |
| K832731 | BREAST & BODY HEALTH SYSTEM 2000 | American Thermal Instruments, Inc. | 1984-01-30 | 179 | 0 |
| K813547 | THERMASCAN | Bcd Products, Inc. | 1982-03-12 | 81 | 0 |
| K781916 | FLEXT-THERM | E-Z-Em, Inc. | 1979-02-02 | 80 | 0 |
| K770986 | FLEXI-THERM FILM | E-Z-Em, Inc. | 1977-09-12 | 104 | 0 |
| K770678 | ELC-THERMO-SYSTEM | Cutter Laboratories, Inc. | 1977-05-25 | 44 | 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