Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NFB — Predicate Candidate Screening
71 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
270 days90th percentile
71clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250322 | Respond OC Conserving Regulator (130-0800) | Responsive Respiratory | 2025-07-24 | 170 | 0 |
| K220591 | Proxima | Dynasthetics, LLC | 2022-12-15 | 289 | 0 |
| K221014 | Effortless Oxygen Conserver System Models Effortless Pro and | Effortless Oxygen, LLC | 2022-10-17 | 195 | 0 |
| K200401 | Apogee | Incoba Ltd D/B/A Dynaris | 2020-11-14 | 270 | 0 |
| K151506 | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Ca | Salter Labs | 2016-03-11 | 281 | 0 |
| K131023 | THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN | Medical Products, LLC | 2013-10-11 | 182 | 0 |
| K113111 | CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH | Inovo, Inc. | 2011-12-08 | 49 | 0 |
| K103392 | CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER | Inovo, Inc. | 2010-12-17 | 28 | 0 |
| K090421 | MODEL 350G GAS CONSERVER | Inspired Technologies, Inc. | 2009-05-29 | 100 | 0 |
| K070740 | CHAD THERAPEUTICS BONSAI MODEL 800 | Chad Therapeutics, Inc. | 2007-05-07 | 52 | 0 |
| K060751 | INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR | Inovo, Inc. | 2006-07-18 | 119 | 0 |
| K060382 | FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II | Ameriflo Corp. | 2006-04-19 | 64 | 0 |
| K052563 | INOGEN SATELLITE CONSERVER, MODEL SC-100 | Medical Electronic Devices, Inc. | 2005-10-24 | 35 | 0 |
| K051540 | INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR | Inovo, Inc. | 2005-09-21 | 103 | 0 |
| K051988 | OXY-SERVE II OXYGEN CONSERVING REGULATOR | Superior Products, Inc. | 2005-09-21 | 61 | 1 |
| K051007 | ACCU02 SYSTEM | Miti Corp. | 2005-06-16 | 57 | 0 |
| K042142 | CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S | Chad Therapeutics, Inc. | 2004-09-20 | 42 | 0 |
| K041057 | FLO-RITE | Ameriflo Corp. | 2004-08-12 | 111 | 0 |
| K041568 | EOCD | Respironics, Inc. | 2004-07-21 | 41 | 0 |
| K033197 | INOGEN SATELLITE CONSERVER | Medical Electronic Devices, Inc. | 2004-05-13 | 224 | 0 |
| K033364 | CHAD THERAPEUTICS SAGE | Chad Therapeutics, Inc. | 2004-05-11 | 203 | 0 |
| K024023 | ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONS | Essex Medical Systems Plus | 2003-10-01 | 300 | 0 |
| K031983 | INOVO, INC, ECONOMIZER CONSERVING REGULATOR | Inovo, Inc. | 2003-09-15 | 81 | 0 |
| K032018 | EASY PULSE II OXYGEN CONSERVER | Precision Medical, Inc. | 2003-08-25 | 56 | 0 |
| K023673 | AIRLIFE DEMAND NASAL CANNULA | Allegiance Healthcare Corp. | 2003-05-02 | 182 | 0 |
| K022865 | 6203 | Contemporary Products, Inc. | 2003-02-13 | 169 | 0 |
| K023420 | PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REAC | Medical Electronic Devices, Inc. | 2002-10-25 | 14 | 0 |
| K020475 | CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511 | Chad Therapeutics, Inc. | 2002-07-05 | 143 | 0 |
| K020329 | DEVILBISS PD1000 | Sunrise Medical Hhg, Inc. | 2002-06-19 | 139 | 2 |
| K010747 | OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, M | Western Ent. | 2001-05-16 | 64 | 3 |
| K010389 | CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411 | Chad Therapeutics, Inc. | 2001-03-23 | 42 | 0 |
| K001412 | PM 1800 CONSERVING DEVICE | Precision Medical, Inc. | 2001-03-20 | 320 | 0 |
| K003455 | MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401 | Chad Therapeutics, Inc. | 2000-12-06 | 29 | 1 |
| K002284 | VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX | Invacare Corp. | 2000-10-24 | 90 | 0 |
| K001579 | IMPULSE SELECT | Airsep Corp. | 2000-08-31 | 101 | 0 |
| K992935 | OCD2001 | Contemporary Products, Inc. | 2000-06-20 | 294 | 0 |
| K000890 | CHAD THERAPEUTICS OXYMATIC MODEL 401 | Chad Therapeutics, Inc. | 2000-06-16 | 88 | 1 |
| K992659 | O2N DEMAND-II, VICTOR MODEL OCPR-II | Thermadyne Holings Corp. | 1999-09-03 | 25 | 0 |
| K982943 | TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000 | Transtracheal Systems | 1999-07-12 | 325 | 0 |
| K990678 | PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC) | Salter Labs | 1999-05-07 | 66 | 0 |
| K983601 | DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC | Medical Electronic Devices, Inc. | 1998-12-15 | 62 | 0 |
| K983459 | PULSED OXYGEN CONSERVING DEVICE, POCD | Medical Electronic Devices, Inc. | 1998-12-08 | 69 | 0 |
| K964541 | SANPO I | Koike Medical Co. | 1997-09-26 | 329 | 0 |
| K970371 | FLOTEC OXYSAVRR (S) | Flotec, Inc. | 1997-07-10 | 160 | 0 |
| K963247 | VICTOR MODEL OCPR OXYGEN CONSERVING PRESSURE REGULATOR | Thermadyne Holings Corp. | 1996-11-07 | 80 | 0 |
| K962944 | TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000) | Transtracheal Systems | 1996-10-23 | 89 | 0 |
| K961126 | PULSE DOSE SERIES | Devilbiss Health Care, Inc. | 1996-10-21 | 214 | 0 |
| K962766 | AIRSEP IMPULSE | Airsep Corp. | 1996-10-10 | 86 | 0 |
| K955129 | OXYPULSE EOC I, EOC II & EOC R | Eagle Medical Equipment Co. | 1996-02-16 | 99 | 0 |
| K953852 | MODEL IPD OXYGEN CONSERVING DEVICE | Invacare Corp. | 1995-11-22 | 98 | 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