Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CBK — Predicate Candidate Screening
505 FDA 510(k) clearances under this product code; the 50 most recent screened below.
127 daysmedian FDA review time
385 days90th percentile
505clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253647 | Evita (V800); Evita (V600) | Draegerwerk AG & CO Kgaa | 2026-05-07 | 168 | 0 |
| K252663 | Inbentus Versatile | Iconic Solutions by Murcia, SL | 2026-04-14 | 235 | 0 |
| K251888 | VPAP Pediatric Face Mask | Hsiner Co., Ltd. | 2026-03-12 | 265 | 0 |
| K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | 2025-12-19 | 865 | 0 |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with S | Fisher & Paykel Healthcare, Ltd. | 2025-09-10 | 61 | 0 |
| K243767 | SV600, SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-08-28 | 265 | 0 |
| K251133 | AVEA disposable expiratory filter/water trap (11790) | Telesair, Inc. | 2025-05-08 | 27 | 0 |
| K243394 | AF531 Oro-Nasal SE Face Mask | Respironics, Inc. | 2024-12-30 | 60 | 0 |
| K233486 | 731 Series Ventilator | ZOLL Medical Corporation | 2024-12-13 | 413 | 0 |
| K223120 | Ventoux VC2; Ventoux VC3 | Flight Medical Innovations , Ltd. | 2024-12-02 | 791 | 0 |
| K241135 | RESPOND(R) Ventilator | Corvent Medical, Inc. | 2024-11-13 | 203 | 0 |
| K241943 | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Ven | Sleepnet Corporation | 2024-08-28 | 57 | 0 |
| K232836 | Family of DIMAR DMAX NIV masks | Dimar S.P.A. | 2024-08-14 | 335 | 0 |
| K240807 | VM-2000 | Ventis Medical, Inc. | 2024-08-13 | 141 | 0 |
| K241520 | Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-V | Sleepnet Corporation | 2024-06-27 | 29 | 0 |
| K231778 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, LLC | 2024-03-01 | 259 | 0 |
| K213098 | Panther 5 | Origin Medical Devices | 2023-07-20 | 664 | 0 |
| K220107 | Mindray SV600 Ventilator, Mindray SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023-06-16 | 520 | 0 |
| K222644 | Nihon Kohden NKV-440 Ventilator System | Nihon Kohden Orangemed, Inc. | 2023-05-31 | 272 | 0 |
| K222024 | Evita V800, Evita V600 | Draegerwerk AG & CO Kgaa | 2023-05-16 | 309 | 0 |
| K222207 | Babylog VN800, Babylog VN600 | Draegerwerk AG & CO Kgaa | 2023-05-16 | 295 | 0 |
| K201082 | LTV2 Series Ventilators | Vyaire Medical, Inc. | 2021-11-10 | 566 | 0 |
| K210384 | CARESCAPE R860 | Datex-Ohmeda, Inc. | 2021-11-04 | 268 | 0 |
| K201874 | Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1 | Maquet Critical Care AB | 2021-04-20 | 287 | 4 |
| K203449 | F&P Visairo NIV Mask Range | Fisher & Paykel Healthcare, Ltd. | 2021-04-14 | 142 | 0 |
| K201306 | HAMILTON-C3 | Hamilton Medical AG | 2021-02-05 | 266 | 1 |
| K202970 | Ventway Sparrow | Inovytech Medical Solutions , Ltd. | 2021-01-29 | 121 | 0 |
| K201658 | Hamilton-C6 | Hamilton Medical AG | 2020-12-11 | 176 | 4 |
| K193056 | Puritan Bennett 980 Series Ventilator System | Covidien, LLC | 2020-11-20 | 385 | 17 |
| K192604 | Servo-air 4.0 Ventilator System | Maquet Critica Care AB | 2020-06-18 | 272 | 0 |
| K193228 | Hamilton-G5 | Hamilton Medical AG | 2020-05-04 | 164 | 0 |
| K192307 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, Inc. | 2020-01-10 | 137 | 0 |
| K183364 | Bellavista | Imtmedical AG | 2019-09-13 | 283 | 3 |
| K181216 | HAMILTON-T1, HAMILTON-C1 | Hamilton Medical AG | 2019-08-02 | 452 | 5 |
| K180295 | Hamilton-G5 | Hamiton Medical AG | 2019-07-30 | 544 | 0 |
| K190533 | Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full | Sleepnet Corporation | 2019-07-26 | 144 | 2 |
| K181166 | Trilogy Evo | Respironics, Inc. | 2019-07-18 | 442 | 33 |
| K181170 | Trilogy Evo Universal | Respironics, Inc. | 2019-07-18 | 442 | 12 |
| K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator Sy | Maquet Critical Care AB | 2019-03-19 | 427 | 0 |
| K180779 | Savina 300 | Dragerwerk AG & CO Kgaa | 2019-01-17 | 297 | 0 |
| K181695 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, Inc. | 2018-12-07 | 163 | 0 |
| K173973 | TV-100 | Bio-Med Devices, Inc. | 2018-07-20 | 203 | 0 |
| K172875 | Astral 100/150 | Resmed, Ltd. | 2018-04-26 | 217 | 2 |
| K173060 | F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Stan | Fisher and Paykel Healthcare Limited | 2018-01-25 | 119 | 0 |
| K162738 | Puritan Bennett 980 Ventilator System | Covidien | 2017-10-27 | 392 | 1 |
| K170037 | Breathe Technologies Life2000™ Ventilation System | Breathe Technologies | 2017-08-11 | 219 | 12 |
| K162832 | 731 Series Ventilators | ZOLL Medical Corporation | 2017-08-02 | 295 | 1 |
| K163127 | bellavista 1000 | Imtmedical AG | 2017-07-31 | 265 | 0 |
| K161450 | HAMILTON-C3 | Hamilton Medical AG | 2017-04-27 | 337 | 0 |
| K162877 | VOCSN Unified Respiratory System | Ventec Life Systems, Inc. | 2017-04-07 | 175 | 5 |
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