Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Elekta Instruments, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
262 daysmedian FDA review time
709 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983678 | ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE | Elekta Instruments, Inc. | 1999-01-15 | 87 | 4 |
| K955064 | SPETZLER TI 100 ANEURYSM CLIP | Elekta Instruments, Inc. | 1996-10-17 | 346 | 0 |
| K941823 | LEKSELL NEURO GENERATOR AND ACCESSORIES | Elekta Instruments, Inc. | 1996-03-22 | 709 | 0 |
| K946165 | CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOS | Elekta Instruments, Inc. | 1995-05-23 | 155 | 0 |
| K943468 | LEKSELL SURGIPLAN | Elekta Instruments, Inc. | 1995-01-20 | 185 | 1 |
| K932261 | ES-100 ACCESSORIES | Elekta Instruments, Inc. | 1994-01-07 | 262 | 0 |
| K925360 | ES-100 POWER SYSTEM, ES-100 SERIES | Elekta Instruments, Inc. | 1993-09-07 | 320 | 0 |
| K914808 | LEKSELL GAMMAPLAN (LGP) | Elekta Instruments, Inc. | 1992-01-23 | 90 | 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