Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PHL — Predicate Candidate Screening
25 FDA 510(k) clearances under this product code; the 50 most recent screened below.
172 daysmedian FDA review time
374 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260381 | Eve | Wandercraft SAS | 2026-08-03 | 179 | 0 |
| K250904 | Atalante X | Wandercraft SAS | 2025-10-24 | 212 | 0 |
| K241822 | ReWalk® 7 Personal Exoskeleton (50-20-0005) | Rewalk Robotics Ltd. Dba Lifeward | 2025-03-12 | 261 | 0 |
| K233695 | Medical HAL Lower Limb Type (HAL-ML) | Cyberdyne, Inc. | 2024-05-07 | 172 | 0 |
| K232077 | Atalante X | Wandercraft SAS | 2023-12-13 | 153 | 0 |
| K221696 | ReWalk P6.0 | Re Walk Robotics , Ltd. | 2023-03-02 | 265 | 0 |
| K221859 | Atalante | Wandercraft SAS | 2022-12-29 | 185 | 1 |
| K220988 | EksoNR | Ekso Bionics, Inc. | 2022-06-09 | 66 | 0 |
| K213452 | GEMS-H | Samsung Electronics Co., Ltd. | 2022-04-21 | 177 | 0 |
| K201473 | ExoAtlet-II | Exoatlet Asia Co. , Ltd. | 2021-07-16 | 408 | 0 |
| K201559 | HAL for Medical Use(Lower Limb type) | Cyberdyne, Inc. | 2020-10-02 | 114 | 0 |
| K201539 | Keeogo Dermoskeleton System | B-Temia, Inc. | 2020-09-09 | 92 | 0 |
| K200574 | EksoNR | Ekso Bionics, Inc. | 2020-06-19 | 106 | 0 |
| K200032 | ReWalk P6.0 | Re Walk Robotics , Ltd. | 2020-05-26 | 140 | 0 |
| K190337 | ReWalk Restore | Re Walk Robotics , Ltd. | 2019-06-03 | 109 | 0 |
| K183152 | Phoenix | Us Bionics, Inc. (Dba Suitx) | 2019-04-17 | 154 | 0 |
| K181294 | Honda Walking Assist Device | Honda Motor Company, Ltd. | 2018-12-14 | 212 | 0 |
| K173530 | Indego(R) | Parker-Hannifin Corporation | 2018-01-31 | 77 | 0 |
| K171909 | HAL for Medical Use (Lower Limb Type) | Cyberdyne, Inc. | 2017-12-17 | 174 | 0 |
| K171334 | Indego | Parker Hannifin Corporation | 2017-09-08 | 123 | 0 |
| K160987 | ReWalk(TM) | Rewalk Robotics, Inc. | 2016-07-22 | 105 | 0 |
| K161443 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | Ekso Bionics, Inc. | 2016-07-19 | 55 | 0 |
| K143690 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | Ekso Bionics, Inc. | 2016-04-01 | 464 | 0 |
| K152416 | Indego | Parker Hannifin Corporation | 2016-02-26 | 184 | 0 |
| DEN130034 | REWALK | Argo Medical Technologies, Inc. | 2014-06-26 | 374 | 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