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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Merits Health Products., Inc. · Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

80 daysmedian FDA review time
90 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K012802MP3CF ELECTRIC WHEELCHAIRMerits Health Products., Inc.2001-09-18280
K011844MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORSMerits Health Products., Inc.2001-08-28770
K011513MP3U, POWER WHEELCHAIRMerits Health Products., Inc.2001-08-10860
K011751TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3Merits Health Products., Inc.2001-08-06610
K011687MP-3C POWER BASE CHAIR, MODEL MP3CMerits Health Products., Inc.2001-08-03640
K011753TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4Merits Health Products., Inc.2001-08-03580
K010380MP3HD BIG BOY, POWER WHEELCHAIRMerits Health Products., Inc.2001-05-09900
K003815TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEERMerits Health Products., Inc.2000-12-27160
K993032MODIFICATION TO MP-3 POWER BASE CHAIRMerits Health Products., Inc.1999-11-05870
K982066MP-3 POWER BASE CHAIRMerits Health Products., Inc.1998-08-31810
K933662MERITS WHEELCHAIRMerits Health Products., Inc.1994-03-302460
K933406TRAVEL EASEMerits Health Products., Inc.1993-09-30800

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