Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
NYN · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
181 daysmedian FDA review time
247 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142236 | BioniCare Hand System | Vision Quest Industries, Inc. | 2015-03-23 | 222 | 0 |
| K111557 | X-FORCE | Seven Seas Distribtion and Manufacturing, LLC | 2011-11-10 | 160 | 0 |
| K073386 | JOINT STIM, MODEL 1000 | Pain Management Technologies | 2008-07-30 | 240 | 0 |
| K062325 | RS-4I MUSCLE STIMULATOR FAMILY | Rs Medical | 2007-04-13 | 247 | 0 |
| K052625 | BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 | Bionicare Medical Technologies, Inc. | 2005-12-05 | 73 | 0 |
| K030332 | MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 | Bionicare Medical Technologies, Inc. | 2003-06-06 | 126 | 0 |
| K983228 | BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000 | Murray Electronics | 1999-03-15 | 181 | 0 |
| K971437 | BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000 | Murray Electronics | 1997-07-22 | 95 | 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