Wipro GE Healthcare Private, Ltd.: FDA clearances and approvals
Wipro GE Healthcare Private, Ltd. has 5 FDA 510(k) clearances (first 2010, latest 2013), across 5 product codes in 3 review panels. Median 510(k) review time: 104 days. openFDA lists 10 product recalls by a recalling firm named Wipro GE Healthcare Private, Ltd.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 104 |
| 2013 | 1 | 84 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMT | Warmer, Infant Radiant | 1 | 1 |
| HGM | System, Monitoring, Perinatal | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
| LBI | Unit, Neonatal Phototherapy | 1 | 1 |
| MOS | Coil, Magnetic Resonance, Specialty | 1 | 1 |
Review panels
Most recent Wipro GE Healthcare Private, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123681 | 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL | MOS | 2013-02-22 | 84 |
| K121625 | LULLABY TM WARMER | FMT | 2012-09-14 | 105 |
| K120168 | LULLABY LED PHOTTHERAPY SYSTEM | LBI | 2012-05-02 | 104 |
| K110556 | MINI TELEMETRY SYSTEM | HGM | 2011-07-19 | 141 |
| K102104 | GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | IYN | 2010-10-01 | 66 |
Recalls
10 product recalls in 3 recall events; 10 initiated in the last five years. Most recent: 2025-09-05.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Wipro GE Healthcare Private, Ltd.'s product codes (a text match, not an official crosswalk):
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
- C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
- C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
- C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
- C8902 — Magnetic resonance angiography without contrast followed by with contrast, abdomen (via MOS)
Frequently asked questions
How many FDA 510(k) clearances does Wipro GE Healthcare Private, Ltd. have?
Wipro GE Healthcare Private, Ltd. has 5 FDA 510(k) clearances (first 2010, latest 2013), across 5 product codes in 3 review panels.
How long does FDA take to clear Wipro GE Healthcare Private, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Wipro GE Healthcare Private, Ltd.'s cleared 510(k)s is 104 days.
What devices does Wipro GE Healthcare Private, Ltd. make?
Its most frequent FDA product codes are FMT (Warmer, Infant Radiant, 1); HGM (System, Monitoring, Perinatal, 1); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 1).
Has Wipro GE Healthcare Private, Ltd. had device recalls?
openFDA lists 10 product recalls in 3 recall events by a recalling firm whose name matches Wipro GE Healthcare Private, Ltd; the most recent began 2025-09-05. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 5 Wipro GE Healthcare Private, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FMT, Wipro GE Healthcare Private, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.