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

Rs Medical — Predicate Candidate Screening

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

156 daysmedian FDA review time

364 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K112348	RS-4I MUSCLE STIMULATOR	Rs Medical	2012-01-19	156	0
K090951	RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS	Rs Medical	2009-06-05	63	0
K062325	RS-4I MUSCLE STIMULATOR FAMILY	Rs Medical	2007-04-13	247	0
K032652	RS-4I MUSCLE STIMULATOR FAMILY	Rs Medical	2003-09-12	15	1
K021763	RS2MI MUSCLE STIMULATOR FAMILY	Rs Medical	2002-06-13	15	0
K000114	RS-4M+MUSCLE STIMULATOR	Rs Medical	2000-08-10	209	0
K990697	RS-4V MUSCLE STIMULATOR	Rs Medical	1999-06-18	107	0
K953136	RS-4M	Rs Medical	1995-11-30	147	0
K920389	RS-2 NEUROMUSCULAR STIMULATOR	Rs Medical	1993-01-28	364	0
K920388	RS-1 NEUROMUSCULAR STIMULATOR	Rs Medical	1993-01-28	364	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