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

R2 Corp. — Predicate Candidate Screening

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

32 daysmedian FDA review time

141 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K832516	MAGNATRODE CARDIAC MONITORING ELECTRODE	R2 Corp.	1983-12-16	141
K800935	R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS)	R2 Corp.	1980-05-23	32
K800936	R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171	R2 Corp.	1980-05-23	32
K800931	R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122	R2 Corp.	1980-05-23	32
K800932	ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120	R2 Corp.	1980-05-23	32
K800937	R2 PLATE TYPE CABLE-ADAPTOR #S 175,176	R2 Corp.	1980-05-23	32
K800930	R2(TM) ECG ELECTRODE SET-#'S305-306 ETC.	R2 Corp.	1980-05-23	32
K800934	R2 ESU CABLE-ADAPTER MODELS 160,161	R2 Corp.	1980-05-20	29
K800933	R2 ELECTROSURG. RETURN ELECT. #225ETC.	R2 Corp.	1980-05-20	29

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