Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model 10212, 10222, 10202
FDA 510(k) K102120 · Hsiner Co., Ltd.
510(k) numberK102120
Submission
- Device name
- Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model 10212, 10222, 10202
- Applicant
- Hsiner Co., Ltd.
Temecula, CA, US - Received
- July 29, 2010
- Decision date
- August 12, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code CBK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253647 | Evita (V800); Evita (V600)CBK · Traditional | Draegerwerk AG & CO Kgaa | 05/07/2026SE |
| K252663 | Inbentus VersatileCBK · Traditional | Iconic Solutions by Murcia, SL | 04/14/2026SE |
| K251888 | VPAP Pediatric Face MaskCBK · Traditional | Hsiner Co., Ltd. | 03/12/2026SE |
| K232365 | Vivo 45 LSCBK · Traditional | Oconnell Regulatory Consultants, Inc. | 12/19/2025SE |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A…CBK · Traditional | Fisher & Paykel Healthcare, Ltd. | 09/10/2025SE |
| K243767 | SV600, SV800 VentilatorCBK · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 08/28/2025SE |
| K251133 | AVEA disposable expiratory filter/water trap (11790)CBK · Traditional | Telesair, Inc. | 05/08/2025SE |
| K243394 | AF531 Oro-Nasal SE Face MaskCBK · Traditional | Respironics, Inc. | 12/30/2024SE |
| K233486 | 731 Series VentilatorCBK · Traditional | ZOLL Medical Corporation | 12/13/2024SE |
| K223120 | Ventoux VC2; Ventoux VC3CBK · Traditional | Flight Medical Innovations , Ltd. | 12/02/2024SE |
More from Flight Medical Innovations , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251888 | VPAP Pediatric Face MaskCBK · Traditional | 03/12/2026SE |
| K120920 | Hsiner CPAP Silicone Nasal Mask Size Xs/Petite Hsiner Nasal Pillow Mask Hsiner Infant…BZD · Traditional | 07/16/2012SE |
| K091185 | 70530-BACTIAL/VIRAL Filter, 70531-HMEF, 70536-BACTERIAL/VIRAL FilterCAH · Traditional | 07/24/2009SE |
| K082009 | Hsiner Nebulizer Bottle, CPR Masks and Face ShieldsCAF · Special | 08/22/2008SE |
| K070948 | Hsiner Nebulizer BottleCAF · Special | 04/25/2007SE |
| K063268 | Cpap/Vpap Masks, Models 1225, 1205 and 1235BZD · Traditional | 02/23/2007SE |
| K053466 | Hsiner ResuscitatorBTM · Abbreviated | 03/22/2006SE |
| K052811 | Hsiner Jet Nebulizer, Model HS-31100CAF · Traditional | 12/21/2005SE |
Questions and answers
When was Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model 10212, 10222, 10202 cleared by the FDA?
Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model 10212, 10222, 10202 (K102120) received a 510(k) decision of Substantially Equivalent on August 12, 2011, 379 days after the submission was received.
What is the product code of K102120?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.