Atlas FDA

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

Kinsei Shiatsu, Inc. — Predicate Candidate Screening

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

63 daysmedian FDA review time
183 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K952990SPIN ROLLEREKinsei Shiatsu, Inc.1995-09-29930
K952916SHIATSU MASTER MASSAGER CUSHIONKinsei Shiatsu, Inc.1995-08-28630
K950411RELAXU-1Kinsei Shiatsu, Inc.1995-08-021830
K950321SHAPE UP MOMI ROLLERKinsei Shiatsu, Inc.1995-02-14190
K950322RELAXY-THE WONDER HANDKinsei Shiatsu, Inc.1995-02-14190
K950320RELAXY-WONDER KNOCKKinsei Shiatsu, Inc.1995-02-14190

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