Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GYD — Predicate Candidate Screening
13 FDA 510(k) clearances under this product code; the 50 most recent screened below.
177 daysmedian FDA review time
268 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253055 | Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple | Nordic Kinetics AB | 2026-06-17 | 268 | 0 |
| K250153 | Neu Platform | Neuhealth Digital , Ltd. | 2025-04-25 | 94 | 0 |
| K221772 | NeuroRPM | New Touch Digital, Inc. | 2023-03-17 | 269 | 0 |
| K220820 | Parky App | H2o Bilisim Yazilim | 2022-11-17 | 241 | 0 |
| K213519 | Rune Labs Tremor Transducer System | Rune Labs, Inc. | 2022-06-10 | 219 | 0 |
| K211887 | Personal Kinetigraph (PKG) System Gen 2 Plus | Gkc Manufacturing Pty, Ltd. | 2022-03-11 | 263 | 0 |
| K161717 | Personal Kinetigraph (PKG) System | Gkc Manufacturing Pty, Ltd. | 2016-09-20 | 90 | 0 |
| K140086 | PERSONAL KINETIGRAPH (PKG) SYSTEM | Gkc Manufacturing Pty, Ltd. | 2014-08-22 | 220 | 0 |
| K063872 | KINESIA | Cleveland Medical Devices, Inc. | 2007-04-06 | 98 | 0 |
| K010270 | TREMOROMETER | Flexable Systems, Inc. | 2001-07-25 | 177 | 0 |
| K011429 | MODEL 100 ACTIVITY MONITOR | Telecom Medical, Inc. | 2001-07-13 | 65 | 0 |
| K971318 | MM-1 MOVEMENT MONITOR | Axon Instruments, Inc. | 1997-07-28 | 110 | 0 |
| K782036 | TREMOR MONITOR | Columbus Instruments Intl. Corp. | 1979-01-23 | 49 | 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