Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CAN — Predicate Candidate Screening
55 FDA 510(k) clearances under this product code; the 50 most recent screened below.
66 daysmedian FDA review time
202 days90th percentile
55clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162811 | MR Conditional CGA 870 | Essex Industries, Inc. | 2017-03-02 | 147 | 0 |
| K080243 | PORTABLE OXYGEN UNIT SCA900 | San Cheong Co. , Ltd. | 2009-04-07 | 432 | 0 |
| K060265 | REMCORE REMOTE CONTROLLED OXYGEN REGULATOR | Remcore, Inc. | 2006-10-25 | 266 | 0 |
| K061785 | CYL-FIL OXYGEN SYSTEM | Responsive Respiratory, Inc. | 2006-09-07 | 76 | 0 |
| K950777 | OXYGEN REGULATOR | Mada Medical Products, Inc. | 1995-04-14 | 52 | 0 |
| K942751 | VANGUARD SERIES GAS REGULATORS | Buckman Co., Inc. | 1995-02-09 | 244 | 0 |
| K936187 | LSPI PRESSURE REGULATOR | Life Support Products, Inc. | 1994-01-27 | 35 | 0 |
| K932006 | 1500 SERIES REGULATOR | Precision Medical, Inc. | 1993-10-25 | 187 | 0 |
| K921125 | AMBU OXYGEN REGULATOR | Amg, LLC | 1992-09-17 | 191 | 0 |
| K915154 | GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS | C.G.H. Medical, Inc. | 1992-05-27 | 195 | 0 |
| K915505 | REGULATOR FLOWMETER | Lifeguard Medical Products, Inc. | 1992-04-22 | 135 | 0 |
| K914271 | GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F) | C.G.H. Medical, Inc. | 1992-04-13 | 202 | 0 |
| K912174 | SALTER LABS DISPOSABLE NIPPLE AND NUT | Salter Labs | 1991-07-24 | 69 | 0 |
| K901831 | PRECISION MEDICAL OXYGEN REGULATOR | Precision Medical, Inc. | 1990-08-14 | 112 | 1 |
| K901623 | AMBU OXYGEN REGULATOR | Flotec, Inc. | 1990-04-26 | 20 | 0 |
| K895956 | RX02 EMERGENCY MEDICAL OXYGEN | Progressive Medical Applications Corp. | 1990-04-05 | 176 | 0 |
| K900115 | VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B | Ventlab Corp. | 1990-02-22 | 44 | 0 |
| K896152 | PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW. | Puritan Bennett Corp. | 1990-01-09 | 77 | 0 |
| K896128 | PURITAN-BENNETT OXYGEN PRESSURE REGULATOR | Puritan Bennett Corp. | 1990-01-09 | 78 | 0 |
| K894850 | 8053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI | Modern Engineering Co., Inc. | 1989-08-31 | 31 | 0 |
| K894302 | OXYGEN THERAPY REGULATOR | Modern Engineering Co., Inc. | 1989-08-07 | 96 | 0 |
| K893621 | CONCOA PRESSURE REGULATORS | Concoa Controls Corp. of America | 1989-07-28 | 78 | 0 |
| K884927 | BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER | Instrumentation Industries, Inc. | 1989-06-23 | 207 | 0 |
| K891771 | VICTOR MEDICAL OXYGEN THERAPY REGULATOR, MODIFIED | Thermadyne Holings Corp. | 1989-06-23 | 91 | 0 |
| K883483 | AUTOFLOW PART NUMBER PR3241-420 PRESSURE REGULATOR | Autoflow Products, Co. | 1988-10-07 | 52 | 0 |
| K872170 | CRT PORTABLE EMERGENCY OXYGEN INHALATOR | Cost Reduction Technologies, Inc. | 1987-09-03 | 87 | 0 |
| K865077 | ACCU-FLO REGULATOR | Alum-Ox, Inc. | 1987-02-10 | 43 | 0 |
| K863711 | REGULATOR OXYGEN MECHANICAL | Lifeguard Medical Products, Inc. | 1987-01-27 | 126 | 0 |
| K862796 | AIRCO PRESSURE REGULATORS | Airco, Inc. | 1986-08-08 | 17 | 0 |
| K862193 | # 10099/10225/10235/10275/10525/10625/10715/10125 | U.O. Equipment Co. | 1986-07-09 | 30 | 0 |
| K853039 | PRESSURE REGULATOR | Erie Medical | 1986-04-11 | 266 | 0 |
| K861166 | OXYGEN THERAPY REGULATOR OR REGULATOR-FLOWMETER | Victor | 1986-04-01 | 4 | 0 |
| K852333 | DOWNS VPAP CIRCUIT | Vital Signs, Inc. | 1985-10-16 | 138 | 0 |
| K852663 | PORTABLE GASEOUS OXGYEN CONTAINER | Cryogenic Assoc. | 1985-08-29 | 66 | 0 |
| K852649 | PRESSURE REGULATOR/Y CONNECTOR | C.R. Bard, Inc. | 1985-08-02 | 42 | 0 |
| K852374 | OXYGEN REGULATORS #50 PRT & BGT(BGT15,BGT18 | The Timeter Group | 1985-07-12 | 38 | 0 |
| K844622 | SAV-A-LIFE | Southern Medical Products, Inc. | 1985-02-26 | 91 | 0 |
| K850106 | AIRCO NITROUS OXIDE REGULATOR | Airco, Inc. | 1985-01-24 | 13 | 0 |
| K843585 | BEMCO PORTABLE OXYGEN INHALATOR | Bemco, Inc. | 1984-10-12 | 31 | 0 |
| K841367 | AIRCO OXYGEN REGULATOR | Welding Products | 1984-04-13 | 11 | 0 |
| K834061 | SLO-FLO 40AL ADJUST-FLOW REGULATOR | S.L.O. Health Products, Inc. | 1984-01-10 | 46 | 0 |
| K830844 | PORTABLE OXYGEN SYSTEM | Puritan Bennett Corp. | 1983-05-27 | 71 | 0 |
| K813467 | 2002 ADJUSTABLE FLOW REGULATOR | Safety Laboratories West | 1982-01-07 | 27 | 0 |
| K813466 | 4004 CONSTANT FLOW REGULATOR | Safety Laboratories West | 1982-01-07 | 27 | 0 |
| K811430 | ANESTHESIOLOGY DEVICE | Vital Air Oxygen Co. | 1981-06-09 | 18 | 0 |
| K810679 | MS-303-OXYGEN REGULATOR SHIELD | Instrumentation Industries, Inc. | 1981-04-17 | 35 | 0 |
| K810132 | MODEL 2 FLOWMETER | Harris Calorific | 1981-01-28 | 9 | 0 |
| K803207 | REGULATOR, OXYGEN MECHANICAL | Timeter Instrument Corp. | 1981-01-15 | 28 | 0 |
| K802644 | EMERG. OXYGEN KIT #65350 & #65399 CASE | B & F Medical Products, Inc. | 1980-12-22 | 59 | 0 |
| K780750 | O2 CONNECTOR | Diemolding Corp. | 1978-07-27 | 80 | 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