Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JOW — Predicate Candidate Screening
352 FDA 510(k) clearances under this product code; the 50 most recent screened below.
127 daysmedian FDA review time
274 days90th percentile
352clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253555 | Flexitouch® Plus Advanced Pneumatic Compression System | Tactile Medical | 2026-07-31 | 259 | 0 |
| K253386 | DVT Garment | Vistar Medical Supplies Co., Ltd. | 2026-06-25 | 268 | 0 |
| K250242 | Compression Therapy Device (LGT-2202DVT) | Guangzhou Longest Medical Technology Co., Ltd. | 2026-04-24 | 452 | 0 |
| K254267 | NanoPress 760A-BT (760A-BT) | Mego Afek , Ltd. | 2026-02-24 | 56 | 0 |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX) | Bio Compression Systems, Inc. | 2025-12-12 | 256 | 0 |
| K250190 | Sequential Compression System (SCD600) | Shenzhen Comen Medical Instruments Co.,Ltd | 2025-12-08 | 319 | 0 |
| K251466 | VenAir, Sequential Compression System (9P-089000); VenAir, S | Wellell, Inc. | 2025-10-28 | 168 | 0 |
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001) | Manamed, LLC | 2025-09-17 | 131 | 0 |
| K251086 | PnueAira (PNCU-01) | Biotab, LLC | 2025-08-18 | 131 | 0 |
| K250817 | Coretech Compression System (Coretech RHB3003) | Vive Health, LLC | 2025-08-08 | 143 | 0 |
| K241096 | Venera 608 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2025-01-15 | 268 | 0 |
| K240499 | ARTAIRA Arterial Compression Device (AACD01) | Airos Medical, Inc. | 2024-10-11 | 234 | 0 |
| K241746 | UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSE | United Medical Resources, LLC | 2024-10-04 | 108 | 0 |
| K232640 | Venowave VW5 | Thermabright | 2024-06-25 | 305 | 0 |
| K240125 | Therm-X (Home); Therm-X (AT) | Zenith Technical Innovations | 2024-06-21 | 157 | 0 |
| K234155 | Nimbl (model PD08-N1) | Tactile Medical | 2024-06-21 | 175 | 0 |
| K232270 | DVT Motion Pneumatic Compression Device | Koge Micro Tech Co., Ltd. | 2024-03-06 | 219 | 0 |
| K240011 | Lymphedema Compression | Jkh Health Co., Ltd. | 2024-02-23 | 52 | 0 |
| K223228 | Dayspring | Koya Medical, Inc. | 2024-01-04 | 443 | 0 |
| K232300 | ElastiMed SACS | Elastimed , Ltd. | 2023-12-22 | 143 | 0 |
| K231801 | MedHealth DVT compression Devices MHH900S/MHH900E | Medhealth Medical Limited | 2023-12-14 | 177 | 0 |
| K222823 | AeroDVx Arm System | Sun Scientific, Inc. | 2023-09-07 | 353 | 0 |
| K232006 | LEGACY® IPC | Ig Technology, Ltd. | 2023-08-04 | 29 | 0 |
| K230028 | Kendall SCD SmartFlow Controller, Cardinal Health Element Sl | Cardinal Health200, LLC | 2023-04-03 | 89 | 3 |
| K222158 | Capiflo 5001 | K&L Distributing, Inc. | 2023-01-20 | 184 | 0 |
| K223195 | AIROS 6P Sequential Compression Device | Airos Medical, Inc. | 2022-12-09 | 57 | 0 |
| K223193 | AIROS 8P Sequential Compression Device | Airos Medical, Inc. | 2022-12-09 | 57 | 0 |
| K221654 | medi pneumatic compression system (pcs)-genius (Model 652) | Medi USA, LP | 2022-07-07 | 30 | 0 |
| K213577 | VenAir, Sequential Compression System | Apex Medical Corp. | 2022-06-28 | 230 | 0 |
| K220761 | CIRCUL8 Connect DVT Prevention Device | Ortho8, Inc. | 2022-06-03 | 80 | 0 |
| K214053 | Amputee Garment for use with Lympha Press Optimal Plus | Mego Afek AC , Ltd. | 2022-04-14 | 108 | 0 |
| K213313 | Veinoflow SCD (Model: LBTK-M-I 5006) | Dalian Labtek Science & Development Co., Ltd. | 2022-02-09 | 128 | 0 |
| K211937 | SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System | Jiangsu Synecoun Medical Technology Co., Ltd. | 2021-11-18 | 149 | 0 |
| K212731 | Circul8 Pro | Ortho8, Inc. | 2021-11-15 | 77 | 0 |
| K203746 | Venen-trainer (Model: FM150, SFM90) | Shenzhen Pango Electronic Co., Ltd. | 2021-11-10 | 323 | 0 |
| K212287 | Dayspring Lite | Koya Medical, Inc. | 2021-09-21 | 62 | 0 |
| K211235 | CIRCUL8 Luxe DVT Prevention Device | Ortho8, Inc. | 2021-09-08 | 135 | 0 |
| K211200 | WoundExpress | Huntleigh Healthcare , Ltd. | 2021-09-03 | 134 | 0 |
| K211253 | PlasmaWave | Manamed, Inc. | 2021-05-26 | 30 | 0 |
| K210417 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, S | Bio Compression Systems, Inc. | 2021-05-14 | 92 | 0 |
| K203847 | Reprocessed Tri Pulse Compression Garment | Renu Medical, Inc. | 2021-05-07 | 127 | 0 |
| K210885 | Dayspring | Koya Medical, Inc. | 2021-04-23 | 29 | 0 |
| K203353 | DVT-PRO | Daesung Maref Co., Ltd. | 2021-04-22 | 160 | 0 |
| K203310 | SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System | Jiangsu Synecoun Medical Technology Co., Ltd. | 2021-04-02 | 143 | 0 |
| K203417 | DVT-4000S | Daesung Maref Co., Ltd. | 2021-03-28 | 129 | 0 |
| K203052 | Movement and Compressions System (the MAC System) | Recovery Force, LLC | 2021-03-21 | 165 | 0 |
| K193662 | Ezlymph, Ezlymph M | Eezcare Medical Corp | 2021-02-11 | 408 | 0 |
| K202839 | Overlapped Compression Therapy | Jkh Health Co., Ltd. | 2021-01-21 | 118 | 0 |
| K203178 | Flexitouch Plus System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2020-12-20 | 55 | 0 |
| K203016 | DVT-2600 | Daesung Maref Co., Ltd. | 2020-12-05 | 65 | 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