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

Rolcontrol Products, Co., Inc. — Predicate Candidate Screening

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

26 daysmedian FDA review time
26 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K885105SLIDING ARM SUPPORTRolcontrol Products, Co., Inc.1988-12-27150
K885104LAYDOWN ARM SUPPORT MECHANISMRolcontrol Products, Co., Inc.1988-12-27150
K885106REMOVABLE BATTERY POWER SYSTEMRolcontrol Products, Co., Inc.1988-12-27150
K8851031600 LIGHT TOUCH CONTROLRolcontrol Products, Co., Inc.1988-12-27150
K8836784007 MODEL RECLINER CONTROLLERRolcontrol Products, Co., Inc.1988-09-13260
K883672PARALYZED VETERANS OF AMERICA POWER RECLINERRolcontrol Products, Co., Inc.1988-09-13260
K883673POWER MECHANICAL RECLINERRolcontrol Products, Co., Inc.1988-09-13260
K883679WHEELS-OFF QUICK RELEASE AXLE SYSTEMRolcontrol Products, Co., Inc.1988-09-13260
K883674MANUAL SWING ARMRolcontrol Products, Co., Inc.1988-09-13260
K883671805 POWER CHAIR CONVERSION SYSTEMRolcontrol Products, Co., Inc.1988-09-13260

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