Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Energy Life Systems Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
40 daysmedian FDA review time
147 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K951933 | UROTEK RE-USABLE FIBEROPTIC CABLE | Energy Life Systems Corp. | 1995-05-26 | 31 | 0 |
| K945560 | UROTEK LASER CATHETER | Energy Life Systems Corp. | 1995-01-18 | 79 | 0 |
| K945563 | CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM)) | Energy Life Systems Corp. | 1994-12-15 | 38 | 0 |
| K943409 | SIDE-FIRING UROLOGIC REFRACTIVE FIBER | Energy Life Systems Corp. | 1994-08-23 | 40 | 0 |
| K934389 | UROTEK LASER CATHETER | Energy Life Systems Corp. | 1994-02-03 | 147 | 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