Puritan Bennett Legendair XL2
FDA 510(k) K070899 · Nellcor Puritan Bennett
510(k) numberK070899
Submission
- Device name
- Puritan Bennett Legendair XL2
- Applicant
- Nellcor Puritan Bennett
Pleasanton, CA, US - Received
- April 2, 2007
- Decision date
- December 13, 2007
- 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
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| 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 |
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| K052186 | Nellcor Oximax Pulse Oximetry Sensons (Max-A, Max-Al, Max-N, Max-I, Max-PDQA · Special | 11/10/2005SE |
| K051352 | Oximax NPB-40 Handheld Pulse OximeterDQA · Traditional | 08/11/2005SE |
| K050072 | Goodknight 425STBZD · Special | 06/13/2005SE |
| K033973 | Oxisensor II Recycled Sensor and Oximax Recycled SensorNLF · Traditional | 12/13/2004SE |
| K030787 | Shiley Flextra Tracheostomy TubeJOH · Traditional | 11/14/2003SE |
| K030930 | Oximax Softcare Sensors, Models Sc-A, Sc-Pr, Sc-Neo, Sc-NDQA · Traditional | 05/23/2003SE |
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Questions and answers
When was Puritan Bennett Legendair XL2 cleared by the FDA?
Puritan Bennett Legendair XL2 (K070899) received a 510(k) decision of Substantially Equivalent on December 13, 2007, 255 days after the submission was received.
What is the product code of K070899?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.