Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Emg Technology Co., Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
305 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112421 | EMG SUCTION UNIT | Emg Technology Co., Ltd. | 2011-09-01 | 9 | 0 |
| K072634 | EMG TRITON -COMP,MODEL NCA01-XXX SERIES | Emg Technology Co., Ltd. | 2008-11-19 | 428 | 0 |
| K063448 | EMG AC/DC SUCTION UNIT | Emg Technology Co., Ltd. | 2006-11-30 | 15 | 0 |
| K062888 | MIDDLE WHEEL DRIVE POWER CHAIR, CWD01 | Emg Technology Co., Ltd. | 2006-10-24 | 28 | 0 |
| K052438 | EMG HANDLE NEBULIZER NB02 SERIES | Emg Technology Co., Ltd. | 2006-01-31 | 147 | 0 |
| K043520 | EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR | Emg Technology Co., Ltd. | 2005-10-21 | 305 | 2 |
| K043238 | COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES | Emg Technology Co., Ltd. | 2005-07-06 | 226 | 0 |
| K042349 | EMG MODEL SUA01 SUCTION UNIT | Emg Technology Co., Ltd. | 2004-12-16 | 108 | 1 |
| K033206 | EPW FOLDABLE POWER WHEELCHAIR, EPW-03 | Emg Technology Co., Ltd. | 2003-12-18 | 77 | 0 |
| K033204 | ESG 4-WHEEL SCOOTER, ESG-03 | Emg Technology Co., Ltd. | 2003-11-12 | 41 | 0 |
| K023148 | EPW POWERED WHEELCHAIR, GP-201 | Emg Technology Co., Ltd. | 2003-01-24 | 126 | 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