Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
CAF · Predicate Candidate Screening
508 FDA 510(k) clearances under this product code; the 50 most recent screened below.
123 daysmedian FDA review time
297 days90th percentile
508clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260270 | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | FindAir Sp. z o.o. | 2026-06-02 | 125 | 0 |
| K251572 | eRapid with eTrack System | Pari Respiratory Equipment, Inc. | 2025-12-19 | 211 | 0 |
| K251659 | Mesh Nebulizer (H6) | Qingdao Future Medical Technology Co., Ltd. | 2025-11-14 | 168 | 0 |
| K244035 | Portable mesh nebulizer (JM821) | Shenzhen Jermei Medical Device Technology Co., Ltd. | 2025-09-19 | 263 | 0 |
| K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-110 | Joytech Healthcare Co. , Ltd. | 2025-07-02 | 236 | 0 |
| K250022 | HeroTracker Sense | Voluntis | 2025-06-30 | 178 | 0 |
| K250583 | AdheResp Smart Breath-actuated Mesh Nebulizer | Hcmed Innovations Co., Ltd. | 2025-06-20 | 113 | 0 |
| K242354 | AllNEB | Enchant Tek Co. , Ltd. | 2025-04-29 | 264 | 0 |
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Sp | Thayer Medical Corporation | 2024-06-18 | 225 | 0 |
| K232507 | Aerogen®Solo Nebulizer System | Aerogen, Ltd. | 2024-05-10 | 266 | 0 |
| K232523 | Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% | Mankind Pharma Limited | 2024-04-10 | 236 | 0 |
| K231058 | Hudson RCI® AddiPak® Unit Dose Vial | Medline Industries, LP | 2024-01-04 | 266 | 0 |
| K230379 | Portable (Ultrasonic) Nebulizer | Dongguan Simzo Electronic Technology Co., Ltd. | 2023-11-27 | 287 | 0 |
| K230602 | Hudson RCI® TurboMist™ Nebulizer System | Medline Industries, LP | 2023-10-31 | 242 | 0 |
| K223367 | Ochsner Connected Inhaler Sensor | Ochsner Clinic Foundation | 2023-08-30 | 299 | 0 |
| K220145 | Monaghan medical filtered mouthpiece kit | Monaghan Medical Corporation | 2023-08-24 | 582 | 0 |
| K223840 | eRapid Nebulizer System | Pari Respiratory Equipment, Inc. | 2023-08-11 | 232 | 0 |
| K223100 | Hudson RCI AquaTherm III Plus External Adjustable Electronic | Medline Industries, Inc. | 2023-06-27 | 270 | 0 |
| K220955 | Hudson RCI Variable concentration Large Volume Nebulizer (17 | Medline Industires, Inc. | 2023-06-23 | 448 | 0 |
| K222247 | Hailie Sensor NF0110 | Adherium (Nz), Ltd. | 2023-02-08 | 197 | 0 |
| K220869 | Vapotherm Aerosol Adapter AAA-2 | Vapotherm, Inc. | 2022-10-28 | 217 | 0 |
| K221994 | Hailie Sensor NF0107 & NF0108 | Adherium (Nz), Ltd. | 2022-10-04 | 90 | 0 |
| K220622 | Hailie Sensor NF0106 | Adherium (Nz), Ltd. | 2022-07-15 | 134 | 0 |
| K212395 | Nebulizer | Shenzhen Homed Medical Device Co., Ltd. | 2022-03-25 | 235 | 0 |
| K211560 | Airvo Nebulizer Adapter | Fisher & Paykel Healthcare Limited | 2021-12-10 | 204 | 0 |
| K210126 | Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% | The Ritedose Corporation | 2021-12-03 | 318 | 0 |
| K203155 | BreatheSuite MDI V1 | Breathesuite, Inc. | 2021-09-17 | 330 | 0 |
| K211233 | Hailie Sensor NF0109 | Adherium (Nz), Ltd. | 2021-08-18 | 117 | 0 |
| K192971 | Nebulizer Kit | Excellentcare Medical (Huizhou) , Ltd. | 2021-07-08 | 624 | 0 |
| K202171 | Pulmogine Vibrating Mesh Nebulizer | Hcmed Innovations Co., Ltd. | 2021-07-01 | 332 | 0 |
| K201397 | Ultrasonic Mesh Nebulizer | Shenzhen Ivankaca Technology Co., Ltd. | 2021-06-14 | 382 | 0 |
| K203400 | Corrugated tube with mouthpiece accessory | Trudell Medical International | 2021-06-14 | 207 | 0 |
| K201167 | AireHealth NebulizerTM | Airehealth, Inc. | 2020-12-03 | 216 | 0 |
| K182906 | Portable Mesh Nebulizer | Feellife Health, Inc. | 2020-09-27 | 711 | 0 |
| K200063 | AeroEclipse* ONE BAN | Trudell Medical International | 2020-07-17 | 186 | 0 |
| K192633 | GUS831 Compressor Nebulizer | Globalcare Medical Technology Co., Ltd. | 2020-05-01 | 221 | 0 |
| K192724 | Propeller Sensor for Symbicort | Reciprocal Labs Corporation | 2020-03-26 | 181 | 0 |
| K191270 | Proneb Max | Pari Respiratory Equipment, Inc. | 2020-01-23 | 255 | 0 |
| K183586 | CapMedic | Cognita Labs, LLC | 2019-09-13 | 266 | 0 |
| K182638 | Hailie Sensor | Adherium (Nz), Ltd. | 2019-06-19 | 268 | 0 |
| K182573 | Hailie Sensor | Adherium (Nz), Ltd. | 2019-06-07 | 262 | 0 |
| K181405 | Hailie Sensor | Adherium (Nz), Ltd. | 2018-12-10 | 195 | 0 |
| K180871 | Portable Nebulizer | Microbase Technology Corporation | 2018-09-14 | 164 | 0 |
| K171549 | Intelligent Mesh Nebulizer | Qingdao Future Medical Technology Co., Ltd. | 2018-08-31 | 462 | 0 |
| K180770 | Propeller Sensor for Neohaler | Reciprocal Labs Corporation | 2018-08-01 | 131 | 0 |
| K180407 | Smartinhaler | Adherium (Nz), Ltd. | 2018-07-25 | 161 | 0 |
| K170886 | HOMED Mesh Nebulizer | Shenzhen Homed Medical Device Co., Ltd. | 2018-06-21 | 451 | 0 |
| K173825 | MC 300R* Nebulizer | Trudell Medical International | 2018-05-02 | 135 | 0 |
| K173310 | SmartTouch | Adherium (Nz), Ltd. | 2018-03-26 | 159 | 0 |
| K173367 | MC 300* Nebulizer | Trudell Medical International | 2018-02-28 | 125 | 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