Chrysalis Intelligence · Product Codes · BZR

BZR · Mixer, Breathing Gases, Anesthesia Inhalation

Anesthesiology · 7 clearances · 5 unique sponsors

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Device class
Class II
Regulation 868.5330
Total clearances
7
2021-04-22 → 2025-07-14
Last 12 months
0
Unique sponsors
5
Classification details
Medical specialty
Anesthesiology
Review panel
AN
Regulation number
868.5330
Implant
N
Life-sustain / support
Y
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Baldus Sedation GmbH & Co. KG 2 0 2023-09-14
Parker Hannifin 2 0 2024-09-19
Fisher & Paykel Healthcare, Ltd. 1 0 2025-07-14
Maxtec, LLC 1 0 2023-12-04
Dehas Medical Systems GmbH 1 0 2023-01-23
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-07-14 K243917 Fisher & Paykel Healthcare, Ltd. F&P Optiflow Air/Oxygen Flow Source
2024-09-19 K241465 Parker Hannifin Corporation Midas Flowmeter; eAVS
2023-12-04 K231895 Maxtec, LLC Maxtec MaxBlend2+p
2023-09-14 K230987 Baldus Sedation GmbH & Co. KG FlowStar Analog Mixer Flowmeter
2023-07-28 K222794 Baldus Sedation GmbH & Co. KG FlowStar Touch Digital Mixer Flowmeter
2023-01-23 K221494 Dehas Medical Systems GmbH Quality Mix Blender, Oxymixer
2021-04-22 K202480 Parker Hannifin Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50
Data source: openFDA · Generated 2026-10-08 10:51 · Last ingest 2026-10-08T14:51:39.242493 · Pipeline: Chrysalis Intelligence