Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BTT — Predicate Candidate Screening
221 FDA 510(k) clearances under this product code; the 50 most recent screened below.
98 daysmedian FDA review time
331 days90th percentile
221clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254078 | HVT 2.0 | Vapotherm, Inc. | 2026-04-13 | 116 | 0 |
| K251448 | FL-10000U Respiratory Humidifier | Flexicare Medical Limited. | 2026-01-16 | 252 | 0 |
| K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | 2026-01-14 | 252 | 0 |
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling | Fisher & Paykel Healthcare, Ltd. | 2025-12-19 | 66 | 0 |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hud | Medline Industries, LP | 2025-07-02 | 149 | 0 |
| K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Ca | Fisher & Paykel Healthcare, Ltd. | 2025-06-25 | 29 | 0 |
| K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | 2025-01-30 | 142 | 0 |
| K241778 | Hudson RCI Comfort Flo® CubCannula™ | Medline Industries, LP | 2024-12-19 | 182 | 0 |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort F | Medline Industries, LP | 2024-09-27 | 249 | 0 |
| K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask C | Fisher & Paykel Healthcare, Ltd. | 2024-08-08 | 230 | 0 |
| K233707 | HFT150 | Invent Medical Corporation | 2024-06-14 | 207 | 0 |
| K233821 | F&P Optiflow Oxygen Kit (AA451J) | Fisher & Paykel Healthcare, Ltd. | 2024-06-13 | 195 | 0 |
| K222292 | F&P myAirvo 3 | Fisher & Paykel Healthcare | 2024-05-08 | 649 | 0 |
| K231956 | F&P Optiflow+ Duet Nasal Cannula | Fisher & Paykel Healthcare, Ltd. | 2024-02-07 | 219 | 0 |
| K230559 | Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief | Medline Industries, Inc. | 2023-10-26 | 240 | 0 |
| K223863 | BONHAWA Respiratory Humidifier | Telesair, Inc. | 2023-10-13 | 294 | 0 |
| K223684 | F&P 820 Humidification System | Fisher & Paykel Healthcare, Ltd. | 2023-09-05 | 271 | 0 |
| K231380 | AirLife DuoTherm™ Humidification System | Vyaire Medical, Inc. | 2023-08-10 | 90 | 0 |
| K223551 | Sterile Water for Inhalation in 1L Flexoval ® bottles. | Hometa, Inc. | 2023-08-03 | 251 | 0 |
| K220703 | F&P 950 Respiratory Humidifier | Fisher & Paykel Healthcare | 2023-06-16 | 463 | 0 |
| K222197 | F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range | Fisher & Paykel Healthcare, Ltd. | 2023-04-06 | 258 | 0 |
| K222351 | inspired™ VHB20 Heated Humidifier | Vincent Healthcare Products Limited | 2022-12-21 | 139 | 0 |
| K212031 | F&P 850 AirSpiral Adult NIV and NHF Circuit Kit | Fisher & Paykel Healthcare, Ltd. | 2022-04-22 | 297 | 0 |
| K211096 | Optiflow Oxygen Kit | Fisher & Paykel Healthcare, Ltd. | 2022-01-28 | 290 | 0 |
| K203357 | HVT 2.0 | Vapotherm, Inc. | 2021-08-25 | 282 | 0 |
| K201723 | F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling | Fisher & Paykel Healthcare, Ltd. | 2021-03-16 | 266 | 0 |
| K193411 | O2asis Personal Oxygen Humidifier | Perma Pure, LLC | 2020-11-12 | 339 | 0 |
| K191818 | F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) | Fisher & Paykel Healthcare, Ltd. | 2020-03-19 | 258 | 0 |
| K191010 | Palladium High Flow Therapy System | Vapotherm, Inc. | 2019-10-10 | 177 | 0 |
| K162553 | AirSpiral Heated Breathing Tube | Fisher & Paykel Healthcare | 2018-12-20 | 828 | 0 |
| K180474 | TNI softFlow 50 | Tni Medical AG | 2018-10-18 | 238 | 0 |
| K161719 | Salter Labs Bubble Humidifier | Salter Labs | 2017-09-21 | 456 | 0 |
| K163283 | HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 | Hamilton Medical AG | 2017-09-20 | 303 | 0 |
| K162242 | Comfort Flo Humidification System | Teleflexmedical, Inc. | 2017-01-19 | 162 | 2 |
| K160764 | AirLife Autofill Humidification Chamber | Carefusion 2200, Inc. | 2016-08-25 | 157 | 4 |
| K161314 | FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE | Flexicare Medical Limited. | 2016-07-06 | 56 | 0 |
| K152029 | HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC | Hamilton Medical AG | 2016-05-03 | 286 | 0 |
| K143646 | MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E | Fisher & Paykel Healthcare, Ltd. | 2015-03-05 | 73 | 0 |
| K141940 | CONCHASMART COLUMN | Teleflex, Inc. | 2014-11-24 | 130 | 0 |
| K133766 | HUMICARE D900 | Gruendler GmbH | 2014-11-24 | 348 | 0 |
| K140556 | CONCHASMART BREATHING CIRCUIT | Teleflex, Inc. | 2014-09-24 | 203 | 0 |
| K141353 | HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR | Teleflexmedical, Inc. | 2014-08-01 | 70 | 0 |
| K132857 | RESPIRATORY GAS HUMIDIFIER | Pacific Medico Co., Ltd. | 2014-05-01 | 231 | 0 |
| K132017 | HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT | Fisher & Paykel Healthcare, Ltd. | 2014-03-25 | 267 | 0 |
| K131912 | CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFIC | Teleflex, Inc. | 2014-03-06 | 253 | 3 |
| K131957 | MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRC | Fisher & Paykel Healthcare, Ltd. | 2013-12-04 | 160 | 0 |
| K131895 | AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER | Fisher & Paykel Healthcare, Ltd. | 2013-10-24 | 121 | 2 |
| K131388 | TRANSCEND HEATED HUMIDIFIER | Somnetics International, Inc. | 2013-09-26 | 135 | 0 |
| K122885 | MEDISIZE GOLD HEATER AND BOOSTER T-PIECE | Medisize BV | 2013-08-29 | 343 | 0 |
| K122705 | HUMICARE D900 | Grundler GmbH | 2013-05-21 | 259 | 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