Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Roc Chinese-European Industrial Research Society · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022494 | HOME CARE JELLY | Roc Chinese-European Industrial Research Society | 2002-12-02 | 126 | 0 |
| K022518 | J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT | Roc Chinese-European Industrial Research Society | 2002-12-02 | 125 | 0 |
| K014126 | SANIDAD HEALTH-UP TENS MP-73725 | Roc Chinese-European Industrial Research Society | 2002-05-03 | 137 | 0 |
| K011846 | BIOTECH POWERED WHEELCHAIR, C650PW | Roc Chinese-European Industrial Research Society | 2002-01-18 | 220 | 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