Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Comet Ltd. C/O Radiology Resources, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
75 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K912338 | TUBE HOUSING ASSEMBLIES | Comet Ltd. C/O Radiology Resources, Inc. | 1991-08-07 | 75 | 0 |
| K911695 | VARIOUS X-RAY TUBES | Comet Ltd. C/O Radiology Resources, Inc. | 1991-06-19 | 64 | 0 |
| K910842 | DI2000/HS-45-150 X-RAY TUBE INSERT | Comet Ltd. C/O Radiology Resources, Inc. | 1991-03-06 | 7 | 0 |
| K901997 | X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS | Comet Ltd. C/O Radiology Resources, Inc. | 1990-06-06 | 35 | 0 |
| K864749 | TELAMAT | Comet Ltd. C/O Radiology Resources, Inc. | 1987-02-10 | 67 | 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