Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CBF — Predicate Candidate Screening
69 FDA 510(k) clearances under this product code; the 50 most recent screened below.
154 daysmedian FDA review time
399 days90th percentile
69clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240569 | FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber | Fink Engineering Pty, Ltd. | 2024-11-21 | 266 | 0 |
| K220290 | Revitalair 430+ | Us Hyperbaric Network | 2023-05-04 | 457 | 0 |
| K171899 | Revitalair 430F | Oxavita Srl | 2019-11-22 | 879 | 0 |
| K163109 | OxyHeal 4000 Multiplace Hyperbaric Chamber Family | Oxyheal Medical Systems, Inc. | 2017-03-22 | 135 | 0 |
| K152223 | Rectangular Multiplace Hyperbaric Chamber System Product Fam | Oxyheal Medical Systems, Inc. | 2016-04-29 | 266 | 0 |
| K140559 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | Sechrist Industries, Inc. | 2014-05-30 | 86 | 0 |
| K102831 | RSI 4200 | Reimers Systems, Inc. | 2011-08-19 | 324 | 0 |
| K092991 | O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) | Environmental Tectonics Corp. | 2010-08-13 | 319 | 0 |
| K101262 | FLEXI-LITE | Pressure-Tech, Inc. | 2010-06-10 | 36 | 0 |
| K100268 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | Sechrist Industries, Inc. | 2010-04-26 | 87 | 0 |
| K082455 | RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER | Gulf Coast Hyperbarics, Inc. | 2009-05-22 | 269 | 0 |
| K081506 | HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC C | Hyperbaric America, LLC | 2008-07-25 | 57 | 0 |
| K072427 | SIGMA SERIES HYPERBARIC CHAMBER | Perry Baromedical Corp. | 2008-06-11 | 287 | 0 |
| K072757 | DIVE AND SHALLOW AND GRAND DIVE | Summit TO Sea | 2008-02-08 | 134 | 0 |
| K060739 | MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 | Khrunichev State Research & Production Space Centr | 2006-07-21 | 123 | 0 |
| K053498 | HYPEROX 101 | Wjo, Inc. | 2006-03-15 | 89 | 0 |
| K052866 | OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER | Oxyheal Health Group | 2005-12-13 | 63 | 0 |
| K051759 | FLEXI-LITE, MODEL FL-V1.2 | Performance Hyperbarics | 2005-11-17 | 141 | 0 |
| K052713 | MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER | Sechrist Industries, Inc. | 2005-10-28 | 29 | 2 |
| K040145 | ATA HCM MONOPLACE HYPERBARIC SYSTEM | Ata Hyperbaric Chamber Manufacturing | 2005-05-04 | 468 | 0 |
| K041007 | MILLENIUM, MODELS 2000, 2001 AND 2002 | Hyperbaric For Life, LLC | 2004-11-15 | 210 | 0 |
| K030418 | MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER S | Makai Marine Industries, Inc. | 2004-01-29 | 353 | 0 |
| K030713 | BAY AREA HYPERSCIENCES | Bay Area Hypersciences, LLC | 2003-12-19 | 288 | 0 |
| K031649 | SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES | Fink Engineering Pty, Ltd. | 2003-12-05 | 191 | 0 |
| K022214 | MSI I2010 DUAL PLACE HYPERBARIC CHAMBER | Mechidyne Systems, Inc. | 2003-02-26 | 233 | 0 |
| K021689 | PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PA | Pan-America Hyperbarics, Inc. | 2002-10-24 | 154 | 0 |
| K021693 | PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH | Pan-America Hyperbarics, Inc. | 2002-10-24 | 155 | 0 |
| K021690 | PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH | Pan-America Hyperbarics, Inc. | 2002-10-24 | 155 | 0 |
| K020974 | BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER | Environmental Tectonics Corp. | 2002-06-26 | 92 | 0 |
| K011592 | OXYGEN TREATMENT HOOD | Amron International Diving Supply, Inc. | 2002-06-19 | 391 | 0 |
| K011866 | OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 S | Hyperbaric Technologies, Inc. | 2002-06-06 | 357 | 0 |
| K001121 | OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS) | Engineered Medical Technology, Inc. | 2001-11-29 | 601 | 0 |
| K011565 | INFANT OXYGEN TREATMENT HOOD | Gulf Coast Hyperbarics, Inc. | 2001-08-16 | 87 | 0 |
| K011312 | BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM | Khrunichev State Research & Production Space Centr | 2001-07-18 | 79 | 0 |
| K010659 | SEA-LONG MEDICAL TREATMENT HOOD | Sea-Long Medical Systems, Inc. | 2001-05-16 | 71 | 0 |
| K002795 | MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS | Hypertec, Inc. | 2000-12-06 | 90 | 0 |
| K002794 | MODEL 5000 MULTIPLACE HYPERBARIC THERAPY | Hypertec, Inc. | 2000-12-06 | 90 | 0 |
| K001409 | GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER | Hyperbaric Technologies, Inc. | 2000-08-02 | 90 | 0 |
| K993010 | BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER | Environmental Tectonics Corp. | 2000-05-30 | 266 | 0 |
| K990927 | SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER | Perry Baromedical Corp. | 1999-11-12 | 238 | 0 |
| K984313 | HTU3 | Hyox Systems , Ltd. | 1999-10-22 | 324 | 0 |
| K981938 | TAMPA HYPERBARIC MONOPLACE CHAMBER | Tampa Hyperbaric Ent. | 1999-07-06 | 399 | 0 |
| K983648 | SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM | Perry Baromedical Services | 1999-02-24 | 131 | 0 |
| K972908 | SANDS SERIES III HYPERBARIC CHAMBER | Sands Hyperbarics | 1998-07-22 | 350 | 0 |
| K974868 | SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER | Perry Baromedical Corp. | 1998-07-02 | 185 | 0 |
| K952545 | WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM | Wright Industries | 1997-05-28 | 726 | 0 |
| K960389 | HYPERBARIC CHAMBER | Tampa Hyperbaric Ent. | 1996-12-05 | 318 | 0 |
| K962869 | GSP1 - GAS SELECTION PANEL | Reimers Systems, Inc. | 1996-10-23 | 92 | 0 |
| K962871 | ODS1 - HOOD DRIVER | Reimers Systems, Inc. | 1996-10-23 | 92 | 0 |
| K955535 | LOUISVILLE LABS OXYGEN HEAD TENT | Louisville Laboratories, Inc. | 1996-07-01 | 209 | 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