Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Wipro GE Healthcare Private, Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
141 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123681 | 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL | Wipro GE Healthcare Private, Ltd. | 2013-02-22 | 84 | 0 |
| K121625 | LULLABY TM WARMER | Wipro GE Healthcare Private, Ltd. | 2012-09-14 | 105 | 0 |
| K120168 | LULLABY LED PHOTTHERAPY SYSTEM | Wipro GE Healthcare Private, Ltd. | 2012-05-02 | 104 | 0 |
| K110556 | MINI TELEMETRY SYSTEM | Wipro GE Healthcare Private, Ltd. | 2011-07-19 | 141 | 0 |
| K102104 | GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Wipro GE Healthcare Private, Ltd. | 2010-10-01 | 66 | 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