Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Myo/Kinetic Systems, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
163 daysmedian FDA review time
248 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945937 | TE-800 PELVIC FLOOR EXERCISER | Myo/Kinetic Systems, Inc. | 1995-07-14 | 221 | 0 |
| K945292 | TS-700P CONTROL XP ELECTRICAL STIMULATOR | Myo/Kinetic Systems, Inc. | 1995-04-12 | 163 | 0 |
| K944972 | URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY | Myo/Kinetic Systems, Inc. | 1995-03-08 | 148 | 0 |
| K936041 | UROGRAM CYSTOMETROGRAM | Myo/Kinetic Systems, Inc. | 1994-04-18 | 119 | 0 |
| K932611 | NEUROMUSCULAR STIMULATOR | Myo/Kinetic Systems, Inc. | 1994-01-31 | 248 | 0 |
| K932764 | THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P) | Myo/Kinetic Systems, Inc. | 1993-10-01 | 115 | 0 |
| K932399 | THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P) | Myo/Kinetic Systems, Inc. | 1993-08-11 | 85 | 0 |
| K914904 | THERAPEUTIC STIMULATOR 2100 (TS-2100) | Myo/Kinetic Systems, Inc. | 1992-04-28 | 179 | 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