Prima Hyuperinflation System
FDA 510(k) K952021 · Prima, Inc.
510(k) numberK952021
Submission
- Device name
- Prima Hyuperinflation System
- Applicant
- Prima, Inc.
Cleveland, TN, US - Received
- April 28, 1995
- Decision date
- May 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BZR – Mixer, Breathing Gases, Anesthesia Inhalation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5330
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K243917 | F&P Optiflow Air/Oxygen Flow SourceBZR · Traditional | Fisher & Paykel Healthcare, Ltd. | 07/14/2025SE |
| K241465 | Midas Flowmeter; eAVSBZR · Traditional | Parker Hannifin Corporation | 09/19/2024SE |
| K231895 | Maxtec MaxBlend2+pBZR · Traditional | Maxtec, LLC | 12/04/2023SE |
| K230987 | FlowStar Analog Mixer FlowmeterBZR · Traditional | Baldus Sedation GmbH & Co. KG | 09/14/2023SE |
| K222794 | FlowStar Touch Digital Mixer FlowmeterBZR · Traditional | Baldus Sedation GmbH & Co. KG | 07/28/2023SE |
| K221494 | Quality Mix Blender, OxymixerBZR · Traditional | Dehas Medical Systems GmbH | 01/23/2023SE |
| K202480 | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50BZR · Traditional | Parker Hannifin | 04/22/2021SE |
| K173205 | Equinox AdvantageBZR · Traditional | O-Two Medical Technologies, Inc. | 08/29/2018SE |
| K161718 | MaxBlend 2, MaxBlend LiteBZR · Traditional | Maxtec, LLC | 10/27/2016SE |
| K142291 | GMX Series Medical Air/Oxygen BlenderBZR · Traditional | Gentec (Shanghai) Corporation | 05/19/2015SE |
More from Gentec (Shanghai) Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K952022 | Prima Volumn VentilatorssBZO · Traditional | 05/22/1995SE |
| K952020 | Prima Pediatric Anesthesia CircuitsCAI · Traditional | 05/22/1995SE |
| K952019 | Prima Adult Gas Sampling CircuitsCAI · Traditional | 05/22/1995SE |
| K952018 | Prima Coaxial CircuitsCAI · Traditional | 05/22/1995SE |
| K952017 | Prima Mapleson D CircuitCAI · Traditional | 05/22/1995SE |
| K952016 | Prima Pediatric Gas Sampling CircuitsCAI · Traditional | 05/22/1995SE |
| K952015 | Prima FilterCAH · Traditional | 05/22/1995SE |
| K952014 | Prima Adult Temperature Monitoring Anesthesia CircuitsCAI · Traditional | 05/22/1995SE |
| K952013 | Prima Guedel AirwaysBTR · Traditional | 05/22/1995SE |
| K952012 | Prima Custom Anestesia CircuitBZO · Traditional | 05/22/1995SE |
Questions and answers
When was Prima Hyuperinflation System cleared by the FDA?
Prima Hyuperinflation System (K952021) received a 510(k) decision of Substantially Equivalent on May 22, 1995, 24 days after the submission was received.
What is the product code of K952021?
The FDA product code is BZR – Mixer, Breathing Gases, Anesthesia Inhalation, a Class II (moderate risk) device regulated under 21 CFR 868.5330.