Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CCK — Predicate Candidate Screening
306 FDA 510(k) clearances under this product code; the 50 most recent screened below.
100 daysmedian FDA review time
288 days90th percentile
306clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261633 | VisuBreath | Affirm Medical Technologies II, LLC | 2026-07-14 | 57 | 0 |
| K253030 | Capnostream™35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | 2026-05-01 | 224 | 0 |
| K250148 | Medical Gas Analyzer (AG200) | Prior Care Science Technology, Ltd. | 2025-08-28 | 219 | 0 |
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (T | Nihon Kohden Corporation | 2025-06-10 | 169 | 0 |
| K251216 | 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sa | Barbaras Development, Inc. | 2025-06-04 | 47 | 0 |
| K240937 | AIM (N/A) | Inventeur, LLC | 2024-12-16 | 255 | 0 |
| K230915 | AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask | Vyaire Medical, Inc. | 2024-11-12 | 592 | 0 |
| K212425 | MicroTrend System | Exostat Medical, Inc. | 2024-11-07 | 1191 | 0 |
| K222511 | Oxy2Pro | Southmedic, Inc. | 2023-11-21 | 459 | 0 |
| K213767 | Endure ETCO2/02 Nasal Cannula | Endure Industries, Inc. | 2023-09-12 | 650 | 0 |
| K221118 | CO2 Mainstream Sensor | Draegerwerk AG & CO Kgaa | 2023-04-05 | 352 | 0 |
| K210112 | XChange Device, XChange System | Pneuma Therapeutics, Inc. | 2023-01-30 | 741 | 0 |
| K220533 | Endoscopy Oxygen Mask | Engineered Medical Systems, Inc. | 2022-11-16 | 265 | 0 |
| K213911 | Microstream CO2 NanoPod | Covidien, LLC | 2022-07-29 | 226 | 0 |
| K213518 | CARESCAPE CO2 Microstream parameter | Covidien, LLC | 2022-04-12 | 160 | 0 |
| K211171 | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAi | GE Healthcare Finland Oy | 2021-10-21 | 185 | 0 |
| K203762 | Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor | Covidien | 2021-09-17 | 268 | 0 |
| K201590 | EMMA Capnograph | Masimo Corporation | 2021-03-29 | 290 | 0 |
| K210019 | Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mains | Unimed Medical Supplies, Inc. | 2021-03-04 | 59 | 0 |
| K192488 | CO2 Sidestream Module | Beijing Kingst Commercial & Trade Co., Ltd. | 2020-05-22 | 254 | 0 |
| K192446 | CO2 Mainstream Module | Beijing Kingst Commercial & Trade Co., Ltd. | 2020-05-21 | 258 | 0 |
| K200594 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987 , Ltd. | 2020-04-27 | 52 | 0 |
| K192563 | Altera gas Sampling Lines | Meditera Tibbi Malzeme San VE Tic AS | 2020-01-17 | 122 | 0 |
| K190824 | Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3 | Bluepoint Medical GmbH & Co. KG | 2019-12-18 | 261 | 0 |
| K182362 | MaxCap Ped and MaxCap Neo | Maxtec, LLC | 2019-05-23 | 266 | 0 |
| K183394 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCA | GE Healthcare Finland Oy | 2019-05-01 | 145 | 4 |
| K181624 | Microstream Advance Neonatal-Infant Nasal Filter Line with O | Oridion Medical 1987 , Ltd. | 2019-03-22 | 275 | 0 |
| K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Mi | Oridion Medical 1987 , Ltd. | 2019-02-08 | 249 | 11 |
| K181981 | CO2 Sampling Line | Tylenol Medical Instruments Co., Ltd. | 2019-02-06 | 196 | 0 |
| K180902 | MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece D | Medipines Corporation | 2019-01-11 | 280 | 0 |
| K170820 | Capnograph and Oximeter | Cmi Health, Inc. | 2018-07-18 | 485 | 0 |
| K173147 | SuperNO2VA Et Device | Revolutionary Medical Devices, Inc. | 2018-06-20 | 264 | 0 |
| K171828 | ETCO2 Sensor | Orantech, Inc. | 2018-05-31 | 345 | 0 |
| K171678 | Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 1 | Vyaire Medical, Inc. | 2018-04-30 | 328 | 0 |
| K172365 | Panoramic Oxygen Mask (POM) | Pom Medical, LLC | 2018-04-19 | 258 | 0 |
| K171235 | OmniCap | Respirion, Inc. | 2018-01-04 | 252 | 0 |
| K172904 | IntelliVue Capnography Extension, IntelliVue Microstream Ext | Philips Medizin Systeme Boeblingen GmbH | 2017-12-26 | 95 | 0 |
| K171765 | Nihon Kohden CO2 Monitor | Nihon Kohden Corporation | 2017-10-11 | 119 | 1 |
| K171028 | CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCA | GE Healthcare Finland Oy | 2017-08-17 | 134 | 4 |
| K161250 | OC-FLEX Flexible IntraOral Cannula | Venture Therapeutics, Inc. | 2017-03-17 | 318 | 0 |
| K161860 | TG-970P CO2 Sensor Kit | Nihon Kohden Corporation | 2017-02-24 | 233 | 0 |
| K162343 | Westmed Gas Sampling Cannula with O2 delivery | Westmed, Inc. | 2016-12-14 | 114 | 0 |
| K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 O | Salter Labs | 2016-03-10 | 287 | 0 |
| K150245 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCA | GE Healthcare Finland Oy | 2015-07-17 | 165 | 4 |
| K150272 | Capnostream 35 Portable Respiratory Monitor | Oridion Medical 1987 , Ltd. | 2015-07-17 | 163 | 0 |
| K143127 | CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sa | Dispo-Med (Malaysia) Sdn Bhd | 2015-02-13 | 105 | 0 |
| K143469 | SOFTECH Plus ETCO2 Cannula | Teleflexmedical, Inc. | 2015-02-12 | 69 | 0 |
| K143150 | CO2 monitoring line with and without in-line filter | Besmed Health Business Corp | 2015-02-05 | 94 | 0 |
| K142467 | IntelAir Nasal Airway Support System | Abeon Medical Corporation | 2014-11-24 | 82 | 0 |
| K123690 | CAPNOSTREAM20P WITH HIFI C02 MONITORING | Oridion Medical 1987 , Ltd. | 2014-08-05 | 610 | 1 |
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