Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BZD — Predicate Candidate Screening
461 FDA 510(k) clearances under this product code; the 50 most recent screened below.
126 daysmedian FDA review time
300 days90th percentile
461clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253044 | RXiBreeze PAP System (RXiBreeze 20C) | Resvent Medical Technology Co., Ltd. | 2026-07-23 | 304 | 0 |
| K253553 | Orion | Resmed Corp | 2026-06-04 | 202 | 0 |
| K254104 | ResScan Essentials | Resmed Corp | 2026-05-27 | 159 | 0 |
| K251920 | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Ma | Dcstar, Inc. | 2026-05-21 | 332 | 0 |
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BMC Medical Co., Ltd. | 2026-04-29 | 215 | 0 |
| K252338 | MySleepDash | Somnetics International, Inc. (Dba Transcend Inc) | 2026-04-17 | 263 | 0 |
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Ven | Sleepnet Corporation | 2026-01-15 | 213 | 0 |
| K253939 | DeltaWave Nasal Pillow System | RemSleep Holdings, Inc. | 2026-01-07 | 29 | 0 |
| K251770 | SleepRes PAP System | Sleepres, Inc. | 2025-12-15 | 188 | 0 |
| K251657 | Personalized Therapy Comfort Settings (PTCS) | Resmed Corp | 2025-12-05 | 189 | 0 |
| K243583 | F&P Nova Nasal Mask | Fisher & Paykel Healthcare Limited | 2025-06-18 | 210 | 0 |
| K250624 | myAir | Resmed Corp | 2025-05-28 | 86 | 0 |
| K243023 | WiZARD 520 Full Face Mask | Wellell, Inc. | 2025-05-23 | 238 | 0 |
| K242547 | AirFit F20 Mask System; AirFit F20 NM Mask System | Resmed Pty , Ltd. | 2025-05-19 | 265 | 0 |
| K242935 | Respiration Data Management Software (PAP Link PC) | BMC Medical Co., Ltd. | 2025-01-15 | 112 | 0 |
| K243225 | Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow M | Genadyne Biotechnologies, Inc. | 2024-12-31 | 84 | 0 |
| K241830 | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask | Sleepnet Corporation | 2024-10-18 | 116 | 0 |
| K241939 | EasyCare Tx 2 | Resmed Corp | 2024-09-27 | 87 | 0 |
| K241216 | myAir | Resmed Corp | 2024-09-26 | 148 | 0 |
| K234134 | AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia | Resmed Pty Ltd (Registration Number: 3004604967) | 2024-09-24 | 270 | 0 |
| K233829 | Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro P | Fisher and Paykel Healthcare Limited | 2024-08-23 | 266 | 0 |
| K233555 | AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak | Philips Respironics | 2024-07-31 | 268 | 0 |
| K241661 | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Ma | Sleepnet Corporation | 2024-07-10 | 30 | 0 |
| K233415 | DELTAWAVE Nasal Pillows System | Remsleep Holdings | 2024-07-02 | 266 | 0 |
| K241469 | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask | Sleepnet Corporation | 2024-06-15 | 22 | 0 |
| K230476 | Oran Park Mask | Resmed Pty Ltd (Registration Number: 3004604967) | 2023-10-19 | 239 | 0 |
| K231313 | Therapy Mask 3100 NC/SP | Respironics, Inc. | 2023-07-28 | 84 | 0 |
| K223747 | Whitsundays Mask System | Resmed Pty Ltd (Registration Number: 3004604967) | 2023-07-06 | 204 | 0 |
| K221436 | F&P 950 Accessory Breathing Circuit Kits | Fisher & Paykel Healthcare, Ltd. | 2023-06-29 | 408 | 0 |
| K223696 | F&P Solo Mask Range | Fisher & Paykel Healthcare, Ltd. | 2023-05-17 | 159 | 0 |
| K212263 | Luna G3 BPAP System | 3B Medical, Inc. | 2022-03-25 | 248 | 0 |
| K212371 | F&P Evora Full Face Mask | Fisher & Paykel Healthcare, Ltd. | 2022-03-18 | 231 | 0 |
| K211155 | Auto CPAP System | BMC Medical Co., Ltd. | 2022-03-09 | 324 | 0 |
| K211274 | iQ 2 Nasal Mask, Phantom 2 Nasal Mask | Sleepnet Corporation | 2022-01-10 | 258 | 2 |
| K210844 | DreamWear Silicone Pillows Mask | Respironics, Inc. | 2021-08-24 | 155 | 0 |
| K210386 | Magneto Nasal Mask | Respironics, Inc. | 2021-07-12 | 153 | 1 |
| K203347 | Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF | Suzhou Yuyue Medical Technology Co., Ltd. | 2021-07-02 | 231 | 0 |
| K203601 | Innova Nasal Non-Vented Mask | Sleepnet Corporation | 2021-04-30 | 142 | 0 |
| K201620 | Luna® G3 BPAP 25A | 3B Medical, Inc. | 2021-01-29 | 228 | 0 |
| K200565 | Galapogos | Resmed Corp | 2021-01-17 | 319 | 0 |
| K203126 | S10 Kirra | Resmed Pty , Ltd. | 2020-12-18 | 60 | 0 |
| K192177 | SysMed S/T | Sysmed (China) Co., Ltd. | 2020-11-25 | 471 | 0 |
| K193206 | WiZARD 510 Nasal Mask | Apex Medical Corp. | 2020-10-29 | 344 | 0 |
| K201439 | Ventilator, Non-continuous (Respirator) | Respironics, Inc. | 2020-09-25 | 116 | 0 |
| K200480 | DreamStation 2 System, DreamStation 2 Advanced System | Respironics, Inc. | 2020-07-10 | 134 | 0 |
| K200089 | F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wi | Fisher & Paykel Healthcare, Ltd. | 2020-06-02 | 139 | 0 |
| K183226 | Care Orchestrator Essence | Respironics, Inc. | 2019-10-18 | 332 | 0 |
| K190713 | F&P Vitera Mask Full Face A Model (Small, Medium, Large), F& | Fisher & Paykel Healthcare, Ltd. | 2019-10-11 | 206 | 0 |
| K190254 | Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Ma | Sleepnet Corporation | 2019-07-05 | 148 | 1 |
| K182394 | WiZARD 310/320 Series CPAP Mask | Apex Medical Corp. | 2019-05-17 | 255 | 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