Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BSZ · Predicate Candidate Screening
189 FDA 510(k) clearances under this product code; the 50 most recent screened below.
111 daysmedian FDA review time
325 days90th percentile
189clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-06-25 | 268 | 0 |
| K252746 | Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) | Drägerwerk AG Co. Kgaa | 2026-05-21 | 265 | 0 |
| K251352 | Codonics Safe Labeling System-Point of Care Station (PCS) (S | Codonics.Incorporated | 2025-07-11 | 72 | 0 |
| K230931 | Atlan | Drägerwerk AG Co. Kgaa | 2023-07-23 | 111 | 9 |
| K213867 | Carestation 750/750c | Datex-Ohmeda, Inc. | 2023-03-28 | 473 | 4 |
| K201957 | A8, A9 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-03-26 | 255 | 6 |
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e A | Maquet Critical Care AB | 2020-03-18 | 335 | 9 |
| K171311 | A5 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-01-12 | 255 | 0 |
| K171292 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-01-12 | 255 | 0 |
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compac | Datex-Ohmeda, Inc. | 2017-11-03 | 120 | 10 |
| K170872 | Aisys CS2 | Datex-Ohmeda, Inc. | 2017-08-15 | 145 | 3 |
| K160665 | FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, | Maquet Critical Care AB | 2017-03-29 | 385 | 0 |
| K151570 | Carestation 620/650/650C | Datex-Ohmeda, Inc. | 2016-01-21 | 225 | 10 |
| K151954 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-10-27 | 104 | 0 |
| K143530 | Aespire View | Datex-Ohmeda, Inc. | 2015-04-24 | 133 | 1 |
| K142552 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-01-23 | 135 | 0 |
| K140264 | MADM | Thornhill Research, Inc. | 2015-01-05 | 336 | 0 |
| K132903 | DRE VENTURA | Dre Medical, Inc. | 2014-07-01 | 288 | 0 |
| K133886 | PERSEUS A500 | Draeger Medical GmbH | 2014-06-20 | 182 | 2 |
| K131790 | A9800 ANESTHESIA WORKSTATION | Oricare, Inc. | 2014-05-09 | 325 | 0 |
| K133958 | FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 | Maquet Critical Care AB | 2014-03-20 | 86 | 8 |
| K132530 | GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) | Datex-Ohmeda, Inc. | 2013-12-20 | 130 | 1 |
| K131945 | GE DATEX-OHMEDA AVANCE CS2 | Datex-Ohmeda | 2013-08-08 | 42 | 1 |
| K122063 | INTELLISAVE AX700 ANESTHESIA SYSTEM | Philips Anesthesia Care | 2013-08-02 | 385 | 0 |
| K123211 | A5 ANESTHESIA DELIVERY SYSTEM | Datascope Corp., Patient Monitoring Division | 2013-02-14 | 125 | 0 |
| K123125 | GE DATEX-OHMEDA AVANCE CS2 | Datex-Ohmeda, Inc. | 2013-02-06 | 125 | 3 |
| K122445 | AESPIRE 7900, AESPIRE VIEW | Datex-Ohmeda | 2012-10-12 | 63 | 4 |
| K113633 | MCKESSON ANESTHESIA CARE | Mckesson Technologies, Inc. | 2012-04-20 | 134 | 1 |
| K103035 | SMARTPILOT VIEW MODEL MK04500 | Draeger Medical GmbH | 2012-03-28 | 532 | 0 |
| K120075 | AM-6000 ANESTHESIA MACHINE | Advanced Instrumentations, Inc. | 2012-01-26 | 16 | 0 |
| K112114 | MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40 | Maquet Critical Care AB | 2012-01-13 | 172 | 1 |
| K112722 | GE DATEX-OHMEDA AVANCE | Datex-Ohmeda, Inc. | 2011-12-16 | 88 | 4 |
| K110213 | GE DATEX-OHMEDA AISYS | Datex-Ohmeda, Inc. | 2011-07-20 | 176 | 7 |
| K102389 | NAVIGATOR APPLICATIONS SUITE | GE Healthcare Finland Oy | 2011-06-10 | 291 | 0 |
| K102182 | MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 | Maquet Critical Care AB | 2011-05-09 | 279 | 0 |
| K102471 | AS3700 ANESTHSIA DELIVERY SYSTEM | Mindray DS USA, Inc. | 2011-02-11 | 165 | 2 |
| K101439 | CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P | Codonics, Inc. | 2011-02-07 | 259 | 0 |
| K092864 | AESPIRE 7900, AESPIRE VIEW | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010-01-12 | 117 | 0 |
| K090892 | GE DATEX-OHMEDA S/5 ADU CARESTATION | GE Healthcare Finland Oy | 2009-04-30 | 30 | 1 |
| K083098 | NAVIGATOR APPLICATIONS SUITE | GE Healthcare Finland Oy | 2009-04-01 | 166 | 0 |
| K090233 | GE DATEX-OHMEDA AISYS | Datex-Ohmeda, Inc. | 2009-03-05 | 34 | 2 |
| K083413 | COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM | Philips Medical Systems | 2008-12-18 | 30 | 0 |
| K081447 | FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO | Draeger Medical AG & Co. KG | 2008-10-08 | 139 | 0 |
| K081844 | GE DATEX-OHMEDA AVANCE | Datex-Ohmeda, Inc. | 2008-08-29 | 60 | 4 |
| K081941 | NAVIGATOR APPLICATIONS SUITE | GE Healthcare Finland Oy | 2008-08-07 | 30 | 0 |
| K072884 | FABIUS MRI | Draeger Medical AG & Co. KG | 2008-07-30 | 295 | 2 |
| K080175 | NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 | Datascope Corp., Patient Monitoring Division | 2008-06-09 | 137 | 2 |
| K073707 | GE DATEX-OHMEDA AISYS | Datex-Ohmeda, Inc. | 2008-01-30 | 30 | 2 |
| K072420 | MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE | Oceanic Medical Products, Inc. | 2008-01-22 | 147 | 0 |
| K071097 | NAVIGATOR APPLICATIONS SUITE | GE Healthcare Finland Oy | 2007-10-10 | 175 | 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