Conchasmart Column
FDA 510(k) K141940 · Teleflex, Inc.
510(k) numberK141940
Submission
- Device name
- Conchasmart Column
- Applicant
- Teleflex, Inc.
Durham, NC, US - Received
- July 17, 2014
- Decision date
- November 24, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5450
- Specialty
- Anesthesiology
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| K254078 | HVT 2.0BTT · Traditional | Vapotherm, Inc. | 04/13/2026SE |
| K251448 | FL-10000U Respiratory HumidifierBTT · Traditional | Flexicare Medical Limited. | 01/16/2026SE |
| K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional | Laboratorios Biogalenic S.A. DE C.V. | 01/14/2026SE |
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| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional | Medline Industries, LP | 07/02/2025SE |
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| K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional | Laboratorios Biogalenic S.A. DE C.V. | 01/30/2025SE |
| K241778 | Hudson RCI Comfort Flo® CubCannulaBTT · Traditional | Medline Industries, LP | 12/19/2024SE |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaBTT · Traditional | Medline Industries, LP | 09/27/2024SE |
More from Medline Industries, LP
| 510(k) | Device | Decision |
|---|---|---|
| K241451 | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch…BTR · Traditional | 02/11/2025SE |
| K153652 | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/SetCAZ · Traditional | 06/21/2016SE |
| K140110 | Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/SetBSO · Traditional | 03/27/2015SE |
| K140556 | Conchasmart Breathing CircuitBTT · Traditional | 09/24/2014SE |
| K131912 | Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart…BTT · Traditional | 03/06/2014SE |
| K123974 | Percutaneous Introducer KitDYB · Traditional | 02/21/2013SE |
| K121403 | Continuous Peripheral Nerve Block Catheter Kit and SetCAZ · Special | 06/20/2012SE |
| K103658 | Flextip Plus Closed Tip Epidural CatherterCAZ · Traditional | 05/16/2012SE |
| K861951 | Modified Teleflex Medical Introducer CatheterDYB · Traditional | 06/19/1986SE |
| K860307 | Peel Away & Split Sheath Percu Cath Introducer SetDYB · Traditional | 05/20/1986SE |
Questions and answers
When was Conchasmart Column cleared by the FDA?
Conchasmart Column (K141940) received a 510(k) decision of Substantially Equivalent on November 24, 2014, 130 days after the submission was received.
What is the product code of K141940?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.