Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Suzhou Master Machinery Manufacturing Co.,Ltd · Predicate Candidate Screening

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

90 daysmedian FDA review time
127 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253870Electric Wheelchair (MP148)Suzhou Master Machinery Manufacturing Co.,Ltd2026-03-04900
K252687Manual Wheelchair (HM305-Air1, HM305-Air2)Suzhou Master Machinery Manufacturing Co.,Ltd2025-11-21870
K251638Mobility Scooter (MS160C)Suzhou Master Machinery Manufacturing Co.,Ltd2025-07-22540
K242982Mobility Scooter (MS160A)Suzhou Master Machinery Manufacturing Co.,Ltd2025-01-311270
K241463Electric Wheelchair (MP201C); Electric Wheelchair (MP201L)Suzhou Master Machinery Manufacturing Co.,Ltd2024-07-18560
K222711HS186B ScooterSuzhou Master Machinery Manufacturing Co.,Ltd2023-01-091230

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