Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
BYJ — Predicate Candidate Screening
55 FDA 510(k) clearances under this product code; the 50 most recent screened below.
52 daysmedian FDA review time
179 days90th percentile
55clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130068 | DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) | Essex Industries, Inc. D/B/A Essex Cryogenics of M | 2013-07-19 | 189 | 0 |
| K113767 | MOUNTED MEDICAL OXYGEN SYSTEM | Essex Industries, Inc. | 2012-06-29 | 191 | 0 |
| K103324 | PRECISION LIQUID OXYGEN SYSTEM | Precision Medical, Inc. | 2011-04-21 | 160 | 0 |
| K101272 | MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 | Essex Industries, Inc. | 2010-08-20 | 106 | 0 |
| K081779 | GOLOX-93 | Respironics, Inc. | 2008-09-19 | 88 | 0 |
| K080023 | MODIFICATION TO: SPIRIT | Caire, Inc. | 2008-06-16 | 164 | 0 |
| K072723 | RESPIRONICS GOLOX | Respironics, Inc. | 2008-03-20 | 176 | 0 |
| K072011 | COPD LIQUID OXYGEN PORTABLE, MODEL 300P | Copd Partners, Inc. | 2007-10-18 | 87 | 0 |
| K071581 | BACKPACK MEDICAL OXYGEN SYSTEM | Essex Cryogenics of Missouri, Inc. | 2007-07-11 | 33 | 0 |
| K050153 | SPIRIT, MODEL HAS | Caire, Inc. | 2005-04-15 | 81 | 1 |
| K050414 | PLIX | Respironics, Inc. | 2005-04-11 | 52 | 0 |
| K041122 | PRECISION LIQUID OXYGEN SYSTEM | Precision Medical, Inc. | 2004-10-04 | 158 | 1 |
| K032143 | LIQUID OXYGEN SYSTEM | Micro Technology Services, Inc. | 2004-03-30 | 260 | 0 |
| K033000 | NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM | Essex Cryogenics of Missouri, Inc. | 2004-03-22 | 179 | 0 |
| K013251 | SPIRIT 300 | Caire, Inc. | 2001-12-18 | 81 | 0 |
| K993220 | PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM | Puritan Bennett Corp. | 1999-10-22 | 25 | 0 |
| K971545 | PROTEGE LIQUID OXYGEN SYSTEM | Healthdyne Technologies, Inc. | 1997-07-25 | 88 | 0 |
| K963956 | PORTABLE LIQUID OXYGEN UNIT AND STATIONARY LIQUID OXYGEN UNI | Southern Research, Inc. | 1996-12-09 | 68 | 0 |
| K941819 | LIQUID OXYGEN STORAGE SUBSYSTEM | Hogan & Hartson | 1994-05-23 | 40 | 0 |
| K933930 | PURITAN-BENNETT COMPANION 550 LIQUID OXYGEN PORTABLE UNIT | Puritan Bennett Corp. | 1994-03-21 | 222 | 0 |
| K926267 | MOBILAIRE LIQUID OXYGEN SYSTEMS | Invacare Corp. | 1993-08-31 | 256 | 0 |
| K903140 | PURITAN-BENNETT COMPAN EMT W/REMOTE LIQ LEV GUAGE | Puritan Bennett Corp. | 1990-09-05 | 50 | 0 |
| K895387 | PURITAN-BENNETT COMPANION EMT LIQUID OXYGEN | Puritan Bennett Corp. | 1990-01-24 | 147 | 0 |
| K895082 | VOYAGER PX | Smith-Perry Corp. | 1990-01-09 | 148 | 0 |
| K882328 | HI FLOW 50 | Minnesota Valley Engineering, Inc. | 1988-06-28 | 22 | 0 |
| K880183 | PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT | Essex Cryogenics of Missouri, Inc. | 1988-04-14 | 90 | 0 |
| K880101 | LIBERATOR 53/STROLLER 50 | Minnesota Valley Engineering, Inc. | 1988-02-29 | 48 | 0 |
| K875352 | HI FLOW PORTABLE LIQUID OXYGEN UNIT | Minnesota Valley Engineering, Inc. | 1988-02-29 | 60 | 0 |
| K872449 | NOMAD (BASE UNIT/PORTABLE UNIT) | Minnesota Valley Engineering, Inc. | 1987-07-21 | 28 | 0 |
| K864280 | ECONOL (PORTABLE) ECONO 30 & 40 LITER BASE UNIT | Smith-Taylor Mfg. Co., Div. Allied Medical Corp. | 1987-01-28 | 90 | 0 |
| K863978 | PORTABLE LIQUID OXYGEN UNIT (MODIFICATION) | Penox Technologies, Inc. | 1986-12-15 | 62 | 0 |
| K863556 | CSI LIQUID OXYGEN SYSTEM | Cryogenic Services, Inc. | 1986-10-15 | 33 | 0 |
| K863205 | SWIVEL COUPLER | Venmill Swivel, Co. | 1986-10-02 | 44 | 0 |
| K860738 | CTC 30, 40, 1 LIQUID OXYGEN LITERS | Cryodyne Technologies, Inc. | 1986-08-06 | 160 | 0 |
| K861503 | COMPANION LIQUID OXYGEN SYSTEM | Puritan Bennett Corp. | 1986-06-25 | 63 | 0 |
| K860937 | MARK 4 LIQUID OXYGEN SYSTEM | Puritan Bennett Corp. | 1986-03-20 | 8 | 0 |
| K853775 | PENOX HIGH FLOW MANIFOLD | Penox Technologies, Inc. | 1985-11-29 | 80 | 0 |
| K853083 | RESERVIOR-MASTERAIR PORTABLE-FREEDOMAIR | Home Medical Supply, Inc. | 1985-09-03 | 42 | 0 |
| K841808 | STROLLER SPRINT | Cryogenic Assoc. | 1984-05-16 | 15 | 0 |
| K840534 | LIQUID OXYGEN SYSTEM | The John Bunn Co. | 1984-03-02 | 23 | 0 |
| K834290 | INSPIRON LIQUID OXYGEN SYSTEM | Inspiron Corp. | 1984-02-04 | 58 | 0 |
| K833994 | PULSAIR I & II | Cryo Corp. | 1983-12-12 | 21 | 0 |
| K832143 | MARK III OXYGEN WALKER SYS. RESERVOIR | Linde Div. Union Carbide Corp. | 1983-08-26 | 52 | 0 |
| K830337 | MARK III OXYGEN WALKER SYS-LOW PRESS | Union Carbide Corp. | 1983-03-17 | 44 | 0 |
| K830498 | LIQUID OXYGEN SYSTEM | Puritan Bennett Corp. | 1983-03-10 | 22 | 0 |
| K820836 | MARK III OXYGEN WALKER SYSTEM | Union Carbide Corp. | 1982-04-15 | 20 | 0 |
| K813453 | UNIT, LIQUID, OXYGEN, PORTABLE | Pensee Medical Corp. | 1982-01-12 | 33 | 0 |
| K812536 | LINDE MARK II | Union Carbide Corp. | 1981-09-23 | 20 | 0 |
| K811162 | FLOWLOCK OXYGEN METER | Lifeguard Medical Products, Inc. | 1981-05-08 | 10 | 0 |
| K810732 | LINDE MARK II OXYGEN RESERV. TYPE OR-4 | Union Carbide Corp. | 1981-03-27 | 10 | 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