Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Selectivemed Components, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
170 daysmedian FDA review time
365 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120922 | GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT | Selectivemed Components, Inc. | 2013-02-07 | 317 | 0 |
| K083756 | GUARDIAN 150 ELECTRODE | Selectivemed Components, Inc. | 2009-06-26 | 191 | 0 |
| K031053 | SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG D | Selectivemed Components, Inc. | 2003-05-20 | 48 | 1 |
| K020476 | MEDION 6000 | Selectivemed Components, Inc. | 2002-05-03 | 80 | 0 |
| K993081 | IO-DRIVE | Selectivemed Components, Inc. | 2000-03-03 | 170 | 0 |
| K946230 | ENDURA REUSABLE TENS AND NMES ELECTRODES | Selectivemed Components, Inc. | 1995-12-22 | 365 | 0 |
| K945676 | GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES | Selectivemed Components, Inc. | 1995-01-30 | 73 | 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