Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Merits Health Products Co., Ltd. · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
159 daysmedian FDA review time
308 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220529 | Merits P335 Powered Wheelchair | Merits Health Products Co., Ltd. | 2022-03-18 | 22 | 0 |
| K142912 | Merits Yoga Power Scooter, S542 | Merits Health Products Co., Ltd. | 2015-06-23 | 260 | 0 |
| K142162 | MERITS TRANSFORMER POWER SCOOTER, S941 | Merits Health Products Co., Ltd. | 2015-05-01 | 268 | 0 |
| K122357 | MERITS MODEL P322FWD POWERED WHEELCHAIR | Merits Health Products Co., Ltd. | 2013-01-09 | 159 | 0 |
| K113577 | MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCH | Merits Health Products Co., Ltd. | 2012-05-08 | 155 | 0 |
| K092859 | MERITS MODEL N SERIES NEBULIZER COMPRESSORS | Merits Health Products Co., Ltd. | 2010-07-02 | 288 | 0 |
| K091716 | MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACC | Merits Health Products Co., Ltd. | 2010-04-02 | 296 | 0 |
| K073110 | MERITS E600 SERIES STAIR LIFT | Merits Health Products Co., Ltd. | 2008-02-06 | 93 | 0 |
| K073513 | MERITS E700 PORCE LIFT | Merits Health Products Co., Ltd. | 2008-01-14 | 31 | 0 |
| K053490 | MERITS HEALTH PRODUCTS PORTABLE NEBULIZER | Merits Health Products Co., Ltd. | 2006-07-24 | 221 | 0 |
| K053230 | MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS | Merits Health Products Co., Ltd. | 2006-05-16 | 179 | 0 |
| K053229 | MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS | Merits Health Products Co., Ltd. | 2006-03-23 | 125 | 0 |
| K060212 | MERITS MODEL E SERIES LIFT CHAIRS | Merits Health Products Co., Ltd. | 2006-03-07 | 39 | 0 |
| K052650 | PIONEER U601 SERIES ASPIRATOR | Merits Health Products Co., Ltd. | 2005-11-04 | 39 | 0 |
| K050430 | MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR | Merits Health Products Co., Ltd. | 2005-08-04 | 167 | 0 |
| K041823 | PIONEER U121 SERIES CPAP | Merits Health Products Co., Ltd. | 2005-05-10 | 308 | 0 |
| K014301 | MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS | Merits Health Products Co., Ltd. | 2002-02-11 | 42 | 0 |
| K013788 | TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5 | Merits Health Products Co., Ltd. | 2001-12-11 | 27 | 0 |
| K952042 | TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEER | Merits Health Products Co., Ltd. | 1996-03-04 | 308 | 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