Babypac
FDA 510(k) K970158 · Pneupac, Inc.
510(k) numberK970158
Submission
- Device name
- Babypac
- Applicant
- Pneupac, Inc.
Wake Forest, NC, US - Received
- January 16, 1997
- Decision date
- April 28, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
More from Flight Medical Innovations , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K040090 | Comppac 200HD; CS12 Power Supply (Aircraft/Vechile); PS11 Power Supply (Mains)BTL · Traditional | 05/27/2004SE |
| K030803 | Parapac 200D Transport, Model V200DBTL · Traditional | 09/29/2003SE |
| K021841 | Comppac Ventilator Models 200 & PS11 Power Supply/ChargerBTL · Traditional | 07/17/2003SE |
| K020899 | Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200DBTL · Traditional | 12/13/2002SE |
| K960515 | ParapacBTL · Traditional | 10/10/1996SE |
| K863410 | Patient Valve with Air EntrainmentBTL · Traditional | 01/12/1987SE |
| K862830 | Models 2R and 3R Pneupac Ventilator/ResuscitatorBTL · Traditional | 10/15/1986SE |
| K843737 | Pneupac Instant Action Ventilator/ResusCBK · Traditional | 10/04/1984SE |
| K832700 | Pneu Pac Ventilator/ResuscitatorsCBK · Traditional | 11/14/1983SE |
| K820220 | Ventilator ModelsCBK · Traditional | 02/18/1982SE |
Questions and answers
When was Babypac cleared by the FDA?
Babypac (K970158) received a 510(k) decision of Substantially Equivalent on April 28, 1998, 467 days after the submission was received.
What is the product code of K970158?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.