Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ximed Medical Systems — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
95 daysmedian FDA review time
424 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K943014 | BALLOON ELECTROSURGICAL PROBES AND DEVICES | Ximed Medical Systems | 1996-03-11 | 626 | 0 |
| K946377 | ELECTROPROBE SINGLE USE ELECTROSURGICAL PROBES | Ximed Medical Systems | 1995-03-24 | 95 | 0 |
| K933757 | HAND-HELD IRRIGATION PUMP | Ximed Medical Systems | 1994-08-26 | 408 | 0 |
| K933458 | SURGICAL TROCARS | Ximed Medical Systems | 1994-05-05 | 295 | 0 |
| K922714 | UNIVERSAL IRRIGATION & SUCTION TUBING SET | Ximed Medical Systems | 1993-08-03 | 424 | 0 |
| K922523 | BIPOLAR ELECTROSURGICAL PROBES & INSTRUMENTS | Ximed Medical Systems | 1992-09-23 | 118 | 0 |
| K903812 | ELECTROPROBE SINGLE-USE SURGICAL PROBE | Ximed Medical Systems | 1990-09-20 | 31 | 0 |
| K900463 | LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS | Ximed Medical Systems | 1990-03-22 | 50 | 0 |
| K892933 | INFRALASE-LASERGUIDE DELIVERY SYSTEM | Ximed Medical Systems | 1989-06-22 | 62 | 0 |
| K890775 | INFRALASE - LASERGUIDE DELIVERY SYSTEM | Ximed Medical Systems | 1989-04-21 | 65 | 0 |
| K891126 | MICROLASE CO2 LASER MICROMANIPULATOR | Ximed Medical Systems | 1989-03-17 | 14 | 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