Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
BZR — Predicate Candidate Screening
55 FDA 510(k) clearances under this product code; the 50 most recent screened below.
120 daysmedian FDA review time
288 days90th percentile
55clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243917 | F&P Optiflow Air/Oxygen Flow Source | Fisher & Paykel Healthcare, Ltd. | 2025-07-14 | 206 | 0 |
| K241465 | Midas Flowmeter; eAVS | Parker Hannifin Corporation | 2024-09-19 | 119 | 0 |
| K231895 | Maxtec MaxBlend2+p | Maxtec, LLC | 2023-12-04 | 159 | 0 |
| K230987 | FlowStar Analog Mixer Flowmeter | Baldus Sedation GmbH & Co. KG | 2023-09-14 | 161 | 0 |
| K222794 | FlowStar Touch Digital Mixer Flowmeter | Baldus Sedation GmbH & Co. KG | 2023-07-28 | 315 | 0 |
| K221494 | Quality Mix Blender, Oxymixer | Dehas Medical Systems GmbH | 2023-01-23 | 245 | 0 |
| K202480 | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 | Parker Hannifin | 2021-04-22 | 237 | 0 |
| K173205 | Equinox Advantage | O-Two Medical Technologies, Inc. | 2018-08-29 | 331 | 0 |
| K161718 | MaxBlend 2, MaxBlend Lite | Maxtec, LLC | 2016-10-27 | 127 | 0 |
| K142291 | GMX Series Medical Air/Oxygen Blender | Gentec (Shanghai) Corporation | 2015-05-19 | 274 | 0 |
| K113687 | EQUINOX RELIEVE | O-Two Medical Technologies, Inc. | 2012-04-30 | 137 | 0 |
| K113232 | MAXMIXING BLOCK | Maxtec, Inc. | 2012-03-01 | 120 | 0 |
| K101286 | SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 | Linde Healthcare AB | 2011-10-20 | 531 | 0 |
| K103317 | RESUSCITATION UNIT 105 | Atom Medical Corporation | 2011-04-20 | 161 | 0 |
| K092484 | HELIOX LOW FLOW SENTRY BLENDER | Cardinal Health 207, Inc. | 2010-04-02 | 232 | 0 |
| K090781 | HELIO2 BLENDER | Precision Medical, Inc. | 2009-08-13 | 143 | 0 |
| K081335 | TENACORE OXYGEN BLENDER, MODEL TB-2000 | Tenacore Holdings, Inc. | 2008-11-14 | 186 | 0 |
| K053232 | PRECISION BLENDER | Precision Medical, Inc. | 2006-01-10 | 53 | 0 |
| K051192 | PRAXAIR MEDICAL AIR MIXER | Praxair, Inc. | 2005-09-06 | 119 | 0 |
| K050381 | CS MEDICAL TTCF GAS DELIVERY SYSTEM | Cs Medical, Inc. | 2005-07-13 | 148 | 0 |
| K031860 | SK MED ME202 MONITORING MIXER | Sk Med | 2004-01-21 | 219 | 0 |
| K031707 | SK MED M201 PLUS MIXER | Sk Med | 2003-08-01 | 60 | 0 |
| K022864 | SK MED M201 MIXER | Sk Med | 2003-04-11 | 226 | 0 |
| K001609 | MALLARD AIR OXYGEN ACCUBLENDER | Mallard Medical, Inc. | 2000-08-10 | 78 | 0 |
| K992503 | SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES | Sechrist Industries, Inc. | 1999-08-10 | 14 | 0 |
| K990293 | ALADDIN II MONITORING OXYGEN/AIR MONITOR | Hamilton Medical, Inc. | 1999-03-16 | 46 | 0 |
| K973646 | BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER | Bird Products Corp. | 1998-05-07 | 225 | 0 |
| K974372 | AIR OXYGE MIXER | Sk Med | 1998-02-05 | 77 | 0 |
| K960359 | ALADDIN MONITORING OXYGEN/AIR MIXER | Hamilton Medical, Inc. | 1996-04-24 | 90 | 0 |
| K953711 | AIR ENTRAINER 900RT008 | Fisher & Paykel Electronics , Ltd. | 1995-11-08 | 91 | 0 |
| K952878 | OXY/STAR LOW FLOW BLENDER | Infrasonics Corp. | 1995-09-25 | 94 | 0 |
| K952021 | PRIMA HYUPERINFLATION SYSTEM | Prima, Inc. | 1995-05-22 | 24 | 0 |
| K943797 | BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER | Bpr Medical, Ltd. | 1995-05-11 | 281 | 0 |
| K925982 | BMD AIR/OXYGEN BLENDER | Biomedical Devices, Inc. | 1993-10-07 | 316 | 0 |
| K925591 | MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST | Merit Medical Systems, Inc. | 1993-09-16 | 315 | 0 |
| K932709 | PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM | Precision Med Products, Ltd. | 1993-07-23 | 49 | 0 |
| K932557 | HYPERINFLATION SYSTEM | Life Shield Healthcare Products, Inc. | 1993-07-22 | 56 | 0 |
| K911962 | BIRD SENTRY AIR/OXYGEN MICROBLENDER | Bird Products Corp. | 1991-10-08 | 159 | 0 |
| K900722 | LOW FLOW N2O/02O MICROBLENDER | Bird Products Corp. | 1990-07-18 | 154 | 0 |
| K895695 | BIRD MICROBLENDER M.R.I. | Bird Products Corp. | 1990-07-06 | 288 | 0 |
| K883833 | NITRONOX(R), FIRST RESPONSE NITRONOX(TM) | Matrix Medica, Inc. | 1989-02-17 | 161 | 0 |
| K883038 | P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER | Bird Products Corp. | 1988-11-16 | 120 | 0 |
| K872278 | SIEMENS O2-AIR MIXER 965 | Siemens Elema AB | 1987-09-03 | 80 | 0 |
| K854769 | LNI MGV MEDICAL GAS MIXER | P.A. Mccauley, Inc. | 1986-06-05 | 190 | 0 |
| K860373 | THE M100 AIR/OXYGEN MIXER | Newport Medical Instruments, Inc. | 1986-05-21 | 107 | 0 |
| K853905 | OHMEDA OXYGEN BLENDER | Ohmeda Medical | 1985-10-16 | 26 | 0 |
| K841789 | SECHRIST AIR-OXYGEN MIXER & ANCILLARY | Shiley, Inc. | 1984-07-26 | 87 | 0 |
| K811393 | DOWNS CAP FLOW GENERATOR | Vital Signs, Inc. | 1981-06-09 | 22 | 0 |
| K802226 | SECHRIST SERIES 3500 AIR-OXYGEN MIXER | Sechrist Industries, Inc. | 1980-09-26 | 14 | 0 |
| K800866 | ROYAL | Trident Dental, Inc. | 1980-05-28 | 42 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda