Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CCL — Predicate Candidate Screening
122 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
260 days90th percentile
122clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | Salter Labs | 2026-07-30 | 93 | 0 |
| K251245 | OxyMinder Pro (10310) | Bio-Med Device, Inc. | 2025-08-11 | 111 | 0 |
| K250002 | Smart Check O2 (MA0236) | Life Spark Medical, LLC | 2025-04-24 | 112 | 0 |
| K221734 | Maxtec MaxO2 ME+p | Maxtec, LLC | 2023-04-01 | 290 | 0 |
| K213933 | Percent Oxygen Sensors | Careox, LLC | 2022-08-19 | 246 | 0 |
| K213948 | OxyMinder | Bio-Med Devices, Inc. | 2022-03-17 | 90 | 0 |
| K173807 | Accu O2 Oxygen Analyzer | Precision Medical, Inc. | 2018-05-02 | 138 | 0 |
| K153659 | MaxO2ME | Maxtec, LLC | 2016-06-10 | 172 | 0 |
| K123195 | CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND A | GE Healthcare Finland Oy | 2013-02-28 | 140 | 4 |
| K122290 | ENVITEC MYSIGN O OXYGEN MEASURING DEVICE | Envitec-Wismar GmbH | 2013-01-23 | 177 | 0 |
| K112402 | ULTRAMAXO2 OXYGEN ANALYER | Maxtec, LLC | 2011-12-14 | 114 | 0 |
| K082655 | ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM1 | Envitec-Wismar GmbH | 2008-11-25 | 74 | 0 |
| K072469 | DIGIFLO CONCENTRATOR ANALYZER | Digiflo, Inc. | 2008-01-03 | 121 | 0 |
| K063096 | PRECISION OXYGEN MONITOR | Precision Medical, Inc. | 2007-02-27 | 140 | 0 |
| K063488 | MAXO2 CU | Maxtec, Inc. | 2007-02-22 | 97 | 0 |
| K053407 | OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M | Analytical Industries, Inc. | 2006-04-05 | 119 | 0 |
| K051092 | DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOV | GE Healthcare | 2005-05-25 | 27 | 2 |
| K041773 | OXYGEN MEDICELS, CITICELS | City Technology Limited | 2004-07-15 | 14 | 0 |
| K040484 | MAXO2+, MODEL A AND AE | Maxtec, Inc. | 2004-06-09 | 105 | 0 |
| K024228 | RX300 OXYGEN ANALYZER | Teledyne Analytical Instruments | 2003-07-17 | 206 | 0 |
| K024155 | MX 300 OXYGEN MONITOR | Teledyne Analytical Instruments | 2003-07-17 | 212 | 0 |
| K023565 | OXICHECK | Caradyne, Ltd. | 2003-03-28 | 156 | 0 |
| K010318 | PRIMA OXYGEN MONITOR | Penlon , Ltd. | 2001-07-23 | 171 | 0 |
| K002382 | 'ALL 2000' % OXYGEN ANALYZER | Analytical Industries, Inc. | 2001-03-14 | 222 | 0 |
| K010382 | 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I | Sensidyne, Inc. | 2001-03-01 | 21 | 0 |
| K002384 | M-XX OXYGEN SENSORS | International Business Strategies | 2000-12-15 | 133 | 0 |
| K000700 | SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR | Sensidyne, Inc. | 2000-08-31 | 183 | 0 |
| K001095 | OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R | Teledyne Analytical Instruments | 2000-06-30 | 87 | 1 |
| K990403 | TED 200T7 OXYGEN MONITOR | Teledyne Electronic Technologies | 2000-02-03 | 359 | 0 |
| K990457 | TED 60T OXYGEN ANALYZER | Teledyne Electronic Technologies | 1999-11-09 | 270 | 0 |
| K991884 | SIEMENS FIO2 SENSOR | Siemens Medical Solutions USA, Inc. | 1999-11-03 | 154 | 0 |
| K984295 | INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS) | Invacare Corp. | 1999-07-09 | 220 | 0 |
| K983500 | PRO2 CHECK OXYGEN INDICATOR | Medical Technology Specialists, Inc. | 1999-03-17 | 162 | 0 |
| K982619 | HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02 | Hewlett-Packard Co. | 1998-08-12 | 16 | 0 |
| K971084 | MODEL 02 OXYGEN ANALYZER | Oxigraf, Inc. | 1998-07-21 | 483 | 0 |
| K973545 | VACU*MED GOLD EDITION OXYGEN GAS ANALYZER | Vacumed, Div. of Vacumetrics, Inc. | 1998-05-26 | 250 | 0 |
| K972992 | CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS | Ceramatec, Inc. | 1998-03-30 | 230 | 0 |
| K973282 | HANDI OXYGEN ANALYZER | Ceramatec, Inc. | 1998-03-04 | 183 | 0 |
| K963177 | TED 191 | Teledyne Brown Engineering | 1997-11-13 | 456 | 0 |
| K963415 | VENTREX OXYGEN SENSOR | Ventrex, LLC | 1996-11-25 | 87 | 0 |
| K943824 | GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION | Ametek, Inc. | 1996-11-01 | 914 | 0 |
| K961644 | MINIOX 3000 OXYGEN MONITOR | Minesafety Appliances Co. | 1996-07-25 | 87 | 0 |
| K951038 | OXYCHECK OXYGEN MONITOR | Oxycheck, Inc. | 1996-01-11 | 310 | 0 |
| K952736 | PERCENT OXYGEN SENSOR | Analytical Industries, Inc. | 1995-10-18 | 125 | 0 |
| K953351 | SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS | Seatronics Co. | 1995-10-16 | 91 | 0 |
| K941793 | OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.) | Mountain Medical Equipment, Inc. | 1995-06-21 | 436 | 0 |
| K944120 | FI02 SENSING MODULE | Core-M, L.P. | 1995-05-10 | 260 | 0 |
| K942593 | OXYCHEK OXYGEN ANALYZER | Nidek Medical Products, Inc. | 1995-05-03 | 336 | 0 |
| K944654 | OXYGEN CONCENTRATION INDICATOR | Aequitron Medical, Inc. | 1994-11-08 | 48 | 0 |
| K935364 | MINIOX 1000 OXYGEN CONCENTRATION INDICATOR | Minesafety Appliances Co. | 1994-06-14 | 222 | 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