Knightstar 330 Ventilator
FDA 510(k) K003075 · Mallinckrodt, Inc.
510(k) numberK003075
Submission
- Device name
- Knightstar 330 Ventilator
- Applicant
- Mallinckrodt, Inc.
St. Louis, MO, US - Received
- October 3, 2000
- Decision date
- December 11, 2001
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
Device classification
- Product code
- MNT – Sv70 Ventilator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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|---|---|---|---|
| K252182 | SV70 Ventilator (SV70)MNT · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/06/2026SE |
| K242931 | HFT750UMNT · Traditional | Mekics Co., Ltd. | 05/15/2025SE |
| K240779 | Vivo 3MNT · Traditional | Breas Medical AB | 12/13/2024SE |
| K233643 | F&P Airvo 3 NIV (PT311US)MNT · Traditional | Fisher & Paykel Healthcare, Ltd. | 08/09/2024SE |
| K230173 | Servo-air Lite Ventilator SystemMNT · Traditional | Maquet Critical Care AB | 07/06/2023SE |
| K213521 | Nihon Kohden NKV-330 Ventilator SystemMNT · Traditional | Nihon Kohden Orangemed, Inc. | 07/01/2022SE |
| K191624 | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve VersionMNT · Traditional | Fisher & Paykel Healthcare Limited | 03/09/2020SE |
| K170367 | Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large…MNT · Traditional | Fisher and Paykel Healthcare Limited | 08/24/2017SE |
| K122715 | Stellar 150MNT · Traditional | Resmed Germany, Inc. | 06/17/2013SE |
| K121623 | BIPAP a 40 Ventilatory Support SystemMNT · Abbreviated | Respironics, Inc. | 12/14/2012SE |
More from Respironics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K003315 | Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner CannulaJOH · Special | 11/08/2000SE |
Questions and answers
When was Knightstar 330 Ventilator cleared by the FDA?
Knightstar 330 Ventilator (K003075) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on December 11, 2001, 434 days after the submission was received.
What is the product code of K003075?
The FDA product code is MNT – Sv70 Ventilator, a Class II (moderate risk) device regulated under 21 CFR 868.5895.