Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Machlett Laboratories, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K813158 | RDP-2000 | Machlett Laboratories, Inc. | 1982-01-19 | 64 | 0 |
| K810254 | 1.5` FOCAL SPOT RESOLUTION PATTERN | Machlett Laboratories, Inc. | 1981-02-19 | 20 | 0 |
| K802888 | RAYTHEON MEDICAL IMAGING | Machlett Laboratories, Inc. | 1981-01-09 | 53 | 0 |
| K780969 | GAMMA CAMERA | Machlett Laboratories, Inc. | 1978-06-27 | 15 | 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