Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ximed/Prosure/Injectx — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
162 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002269 | ELECTROSURGICAL PROBES AND DEVICES-GELTX | Ximed/Prosure/Injectx | 2001-01-04 | 162 | 0 |
| K994151 | PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES | Ximed/Prosure/Injectx | 2000-03-01 | 83 | 0 |
| K983200 | INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX | Ximed/Prosure/Injectx | 1998-12-11 | 88 | 0 |
| K983765 | INJECTION NEEDLE PROBE/DEVICE-TUNIS | Ximed/Prosure/Injectx | 1998-12-11 | 46 | 0 |
| K981256 | ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE | Ximed/Prosure/Injectx | 1998-05-12 | 40 | 0 |
| K974484 | ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE | Ximed/Prosure/Injectx | 1998-02-10 | 76 | 0 |
| K974637 | ELECTRODES/PROBES/DEVICES | Ximed/Prosure/Injectx | 1998-01-07 | 26 | 0 |
| K962593 | ELECTROSURGICAL PROBES & DEVICES | Ximed/Prosure/Injectx | 1996-11-12 | 133 | 0 |
| K945995 | BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS | Ximed/Prosure/Injectx | 1995-01-31 | 117 | 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