Single Use Manometer
FDA 510(k) K201666 · Flexicare Medical Limited.
510(k) numberK201666
Submission
- Device name
- Single Use Manometer
- Applicant
- Flexicare Medical Limited.
Mountain Ash, GB - Received
- June 19, 2020
- Decision date
- November 13, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAP – Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2600
- Specialty
- Anesthesiology
Other 510(k)s with product code CAP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182292 | VORTRAN APM-PlusCAP · Traditional | Vortran Medical Technology 1, Inc. | 09/18/2019SE |
| K180510 | NS 120P-TRS Airway Pressure GaugeCAP · Traditional | Instrumentation Industries, Inc. | 05/01/2019SE |
| K172284 | NAPA LP-15 Airway Pressure MonitorCAP · Traditional | Drw Medical, LLC | 02/09/2018SE |
| K153733 | VORTRAN ManometerCAP · Traditional | Vortran Medical Technology 1, Inc. | 09/16/2016SE |
| K143148 | Disposable Pressure Manometer (DPM)CAP · Traditional | Westmed, Inc. | 08/11/2015SE |
| K140370 | Disposable Pressure ManometerCAP · Traditional | Besmed Health Business Corp | 06/19/2014SE |
| K122627 | Gio Digital Pressure GuagesCAP · Traditional | Galemed Corp. | 08/22/2013SE |
| K122077 | ManometerCAP · Traditional | Intersurgical, Inc. | 01/10/2013SE |
| K120118 | Ventlab Pressurechek Disosable Column ManometerCAP · Traditional | Ventlab Corp. | 05/24/2012SE |
| K103639 | Vortran Airway Pressure Monitor (Vapm)-Adult, Vortran Airway Pressure Monitor (Vapm)-…CAP · Traditional | Vortran Medical Technology 1, Inc. | 09/15/2011SE |
More from Vortran Medical Technology 1, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K254026 | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video…EOQ · Traditional | 09/02/2026SE |
| K251448 | FL-10000U Respiratory HumidifierBTT · Traditional | 01/16/2026SE |
| K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu…BTR · Traditional | 05/20/2025SE |
| K191909 | HepaShield Bacterial Viral Breathing System FilterCAH · Traditional | 03/23/2020SE |
| K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator…BTM · Traditional | 12/07/2018SE |
| K163300 | ThermoShield HME FilterCAH · Traditional | 03/22/2017SE |
| K161314 | Flexicare FL-9000U Respiratory Humidifier BaseBTT · Traditional | 07/06/2016SE |
| K160540 | Flexicare Neonatal Heated Wire Breathing SystemBZE · Traditional | 06/23/2016SE |
| K150900 | Flexicare Heated Wire Breathing SystemsBZE · Traditional | 05/15/2015SE |
| K140473 | DualguardCCK · Traditional | 04/10/2014SE |
Questions and answers
When was Single Use Manometer cleared by the FDA?
Single Use Manometer (K201666) received a 510(k) decision of Substantially Equivalent on November 13, 2020, 147 days after the submission was received.
What is the product code of K201666?
The FDA product code is CAP – Monitor, Airway Pressure (Includes Gauge And/Or Alarm), a Class II (moderate risk) device regulated under 21 CFR 868.2600.