FDA product code · Anesthesiology
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Product code CCK covers Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II device regulated under 21 CFR 868.1400. FDA has cleared 306 devices in this code, 3 of them in the last 12 months. Median review time across the 306 most recent decisions is 100 days. openFDA lists 84 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 868.1400
- Review panel
- Anesthesiology
- Clearances
- 306
What is happening in CCK right now?
CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) has two findings, most consequential first. 2 first-time filers in the last 12 months, Affirm Medical Technologies II, LLC and Prior Care Science Technology, Ltd (K261633, K250148). The code is crowded, scoring 78 of 100 — 151 companies hold a clearance here and 3 arrived in the last 12 months (CCK:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K261633, K250148 |
| Crowding | Context | CCK:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in CCK?
FDA has cleared 306 devices under product code CCK since the 510(k) programme began in 1976, 3 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261633 | VisuBreath | Affirm Medical Technologies II, LLC | |
| K253030 | Capnostream35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | |
| K250148 | Medical Gas Analyzer (AG200) | Prior Care Science Technology, Ltd. | |
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) | Nihon Kohden Corporation | |
| K251216 | 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line | Barbaras Development, Inc. | |
| K240937 | AIM (N/A) | Inventeur, LLC | |
| K230915 | AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask | Vyaire Medical, Inc. | |
| K212425 | MicroTrend System | Exostat Medical, Inc. | |
| K222511 | Oxy2Pro | Southmedic, Inc. | |
| K213767 | Endure ETCO2/02 Nasal Cannula | Endure Industries, Inc. |
How long does FDA review take for CCK?
The median FDA review time for CCK is 100 days, measured across the 306 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in CCK?
openFDA lists 84 recall records against product code CCK. A recall record covers one firm's corrective action and may span many device lots.
Z-1722-2025Open, ClassifiedPhilips North America LLC
Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
Z-1376-2025Open, ClassifiedOridion Medical 1987 Ltd.
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Z-1377-2025Open, ClassifiedOridion Medical 1987 Ltd.
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Z-1378-2025Open, ClassifiedOridion Medical 1987 Ltd.
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Z-1379-2025Open, ClassifiedOridion Medical 1987 Ltd.
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Showing the 5 most recently initiated of 84. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for CCK?
MAUDE holds 4,156 adverse-event reports naming product code CCK, 751 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in CCK unusual?
One month sits above CCK's own expected range: 1 April 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 83 | Insufficient history | No expected range — too little history | |
| 163 | Insufficient history | No expected range — too little history | |
| 208 | Insufficient history | No expected range — too little history | |
| 186 | Insufficient history | No expected range — too little history | |
| 264 | Insufficient history | No expected range — too little history | |
| 133 | Insufficient history | No expected range — too little history | |
| 113 | Insufficient history | No expected range — too little history | |
| 138 | Insufficient history | No expected range — too little history | |
| 100 | Insufficient history | No expected range — too little history | |
| 60 | Insufficient history | No expected range — too little history | |
| 79 | Insufficient history | No expected range — too little history | |
| 72 | Insufficient history | No expected range — too little history | |
| 77 | Insufficient history | No expected range — too little history | |
| 97 | Insufficient history | No expected range — too little history | |
| 88 | Insufficient history | No expected range — too little history | |
| 90 | Insufficient history | No expected range — too little history | |
| 126 | Insufficient history | No expected range — too little history | |
| 137 | Insufficient history | No expected range — too little history | |
| 121 | Insufficient history | No expected range — too little history | |
| 141 | Insufficient history | No expected range — too little history | |
| 128 | Insufficient history | No expected range — too little history | |
| 56 | 66–157 | Below expected (66–157) | |
| 62 | 43–123 | Within expected (43–123) | |
| 90 | 40–132 | Within expected (40–132) | |
| 159 | 44–136 | Above expected (44–136) | |
| 89 | 51–157 | Within expected (51–157) | |
| 58 | 48–158 | Within expected (48–158) | |
| 207 | 46–235 | Within expected (46–235) | |
| 97 | 49–195 | Within expected (49–195) | |
| 71 | 43–199 | Within expected (43–199) | |
| 114 | 24–185 | Within expected (24–185) | |
| 97 | 25–170 | Within expected (25–170) | |
| 120 | 32–183 | Within expected (32–183) | |
| 103 | 42–213 | Within expected (42–213) | |
| 76 | 33–171 | Within expected (33–171) | |
| 110 | 26–180 | Within expected (26–180) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in CCK.
Who has entered CCK in the last year?
2 companies filed in CCK for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Affirm Medical Technologies II, LLC | K261633 | |
| Prior Care Science Technology, Ltd. | K250148 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in CCK?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in CCK?
Across the 306 most recent decisions, these applicants filed most often in CCK.
| Applicant | Recent clearances |
|---|---|
| Oridion Medical 1987 , Ltd. | 17 |
| Datex Division Instrumentarium Corp. | 9 |
| Nihon Kohden America, Inc. | 9 |
| Salter Labs | 8 |
| Biochem International, Inc. | 6 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch CCK
Get an email the morning anything changes in CCK — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.