Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable
FDA 510(k) K171678 · Vyaire Medical, Inc.
510(k) numberK171678
Submission
- Device name
- Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable
- Applicant
- Vyaire Medical, Inc.
Helsinki, FI - Received
- June 6, 2017
- Decision date
- April 30, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
Other 510(k)s with product code CCK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251641 | GF-310R Multigas Unit (GF-310R)CCK · Traditional | Nihon Kohden Corporation | 08/12/2026SE |
| K261633 | VisuBreathCCK · Traditional | Affirm Medical Technologies II, LLC | 07/14/2026SE |
| K253030 | Capnostream35 Portable Respiratory Monitor (PM35MN)CCK · Traditional | Covidien, LLC | 05/01/2026SE |
| K250148 | Medical Gas Analyzer (AG200)CCK · Traditional | Prior Care Science Technology, Ltd. | 08/28/2025SE |
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)CCK · Traditional | Nihon Kohden Corporation | 06/10/2025SE |
| K251216 | 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2…CCK · Traditional | Barbaras Development, Inc. | 06/04/2025SE |
| K240937 | Aim (N/A)CCK · Traditional | Inventeur, LLC | 12/16/2024SE |
| K230915 | AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen MaskCCK · Traditional | Vyaire Medical, Inc. | 11/12/2024SE |
| K212425 | MicroTrend SystemCCK · Traditional | Exostat Medical, Inc. | 11/07/2024SE |
| K222511 | Oxy2ProCCK · Traditional | Southmedic, Inc. | 11/21/2023SE |
More from Southmedic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K230915 | AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen MaskCCK · Traditional | 11/12/2024SE |
| K231380 | AirLife DuoTherm Humidification SystemBTT · Traditional | 08/10/2023SE |
| K201082 | LTV2 Series VentilatorsCBK · Traditional | 11/10/2021SE |
| K211294 | Multi-Link X2 ECG Cable and Leadwire SystemDSA · Traditional | 08/16/2021SE |
| K200510 | Multi-LinkTM X2 ECG Adapter and LeadwiresDSA · Traditional | 10/09/2020SE |
| K191273 | Multi-Link X2 ECG and SpO2 AdapterDSA · Traditional | 09/13/2019SE |
| K183567 | Vyntus/SentrySuite Product LineBZC · Traditional | 08/23/2019SE |
| K190853 | Vyntus BODYBZC · Traditional | 08/16/2019SE |
| K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…BZC · Traditional | 11/30/2018SE |
| K170378 | AirLife Adult Heated Wire BiPAP/NIV CircuitBZE · Traditional | 09/14/2017SE |
Questions and answers
When was Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable cleared by the FDA?
Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable (K171678) received a 510(k) decision of Substantially Equivalent on April 30, 2018, 328 days after the submission was received.
What is the product code of K171678?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.