Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cobe Laboratories, Inc. — Predicate Candidate Screening
77 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
147 days90th percentile
77clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K923272 | COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR | Cobe Laboratories, Inc. | 1993-05-11 | 309 | 0 |
| K900105 | COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC | Cobe Laboratories, Inc. | 1991-03-22 | 437 | 0 |
| K905793 | COBE CENTRY 2 BICART OPTION KIT | Cobe Laboratories, Inc. | 1991-02-12 | 47 | 0 |
| K905388 | COBE CENTRYSYSTEM 3 BICART OPTION KIT | Cobe Laboratories, Inc. | 1991-02-11 | 73 | 0 |
| K904336 | NEW COBE SATURATION/HEMATOCRIT MONITOR | Cobe Laboratories, Inc. | 1990-12-27 | 98 | 0 |
| K902437 | COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER | Cobe Laboratories, Inc. | 1990-12-17 | 196 | 0 |
| K902631 | COBE ICU CONVERSION KIT | Cobe Laboratories, Inc. | 1990-12-17 | 186 | 0 |
| K904566 | NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER | Cobe Laboratories, Inc. | 1990-12-12 | 64 | 0 |
| K902758 | COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC | Cobe Laboratories, Inc. | 1990-08-23 | 59 | 0 |
| K902759 | COBE CLOSED WOUND DRAINAGE KIT | Cobe Laboratories, Inc. | 1990-07-18 | 23 | 0 |
| K902671 | COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER | Cobe Laboratories, Inc. | 1990-07-17 | 29 | 0 |
| K900910 | COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) | Cobe Laboratories, Inc. | 1990-05-22 | 84 | 0 |
| K900758 | HEPARINIZED ARTERIAL SCREEN BLOOD FILTER | Cobe Laboratories, Inc. | 1990-05-17 | 90 | 0 |
| K895076 | CMS VRB-1200 | Cobe Laboratories, Inc. | 1989-11-03 | 81 | 0 |
| K893962 | COBE 2991 SUPPLEMENTARY DISPOSABLE SETS | Cobe Laboratories, Inc. | 1989-10-18 | 138 | 0 |
| K881811 | COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS | Cobe Laboratories, Inc. | 1988-09-15 | 140 | 0 |
| K881330 | COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK | Cobe Laboratories, Inc. | 1988-06-10 | 73 | 39 |
| K881062 | CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002 | Cobe Laboratories, Inc. | 1988-04-21 | 38 | 0 |
| K880021 | COBE CML3 | Cobe Laboratories, Inc. | 1988-04-01 | 87 | 0 |
| K870976 | ONGUARD 1000, CATALOG #043611-000 & 043611-001 | Cobe Laboratories, Inc. | 1987-05-06 | 57 | 0 |
| K864831 | COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS | Cobe Laboratories, Inc. | 1987-03-27 | 108 | 0 |
| K861808 | VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN | Cobe Laboratories, Inc. | 1986-09-15 | 129 | 0 |
| K861860 | COBE ACCESSORY INTERFACE MODULE (AIM) | Cobe Laboratories, Inc. | 1986-07-18 | 65 | 0 |
| K855064 | SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE | Cobe Laboratories, Inc. | 1986-03-12 | 84 | 0 |
| K855065 | PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE | Cobe Laboratories, Inc. | 1986-02-28 | 72 | 0 |
| K855067 | SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 | Cobe Laboratories, Inc. | 1986-02-26 | 70 | 0 |
| K855066 | SWANK ARTERIAL LINE BLOOD FILTER HF6000 | Cobe Laboratories, Inc. | 1986-02-26 | 70 | 0 |
| K853101 | VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES | Cobe Laboratories, Inc. | 1986-02-24 | 216 | 0 |
| K853817 | COBE REN NEW-D DISPENSING KIT | Cobe Laboratories, Inc. | 1985-10-17 | 35 | 0 |
| K853100 | COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT | Cobe Laboratories, Inc. | 1985-09-25 | 64 | 0 |
| K851289 | COBE GAS FILTER | Cobe Laboratories, Inc. | 1985-06-19 | 79 | 0 |
| K851306 | COBE SYSTEM 3 | Cobe Laboratories, Inc. | 1985-06-12 | 72 | 0 |
| K842908 | VARIABLE PRIME COBE MEMBRANE LUNG | Cobe Laboratories, Inc. | 1985-02-01 | 192 | 0 |
| K843709 | COBE SATURATION CELL | Cobe Laboratories, Inc. | 1984-10-24 | 33 | 0 |
| K842138 | COBE EMERGENCY POWER SOURCE 43610-000 | Cobe Laboratories, Inc. | 1984-08-03 | 65 | 0 |
| K842054 | COBE AEPS | Cobe Laboratories, Inc. | 1984-08-02 | 72 | 0 |
| K840680 | CENTRY 2000 DIALYSIS CONTROL UNIT | Cobe Laboratories, Inc. | 1984-04-20 | 65 | 0 |
| K832671 | CARDIOTOMY RESERVOIR-FILTER 050-108-050 | Cobe Laboratories, Inc. | 1983-12-27 | 140 | 0 |
| K830629 | COBE RX METER | Cobe Laboratories, Inc. | 1983-04-06 | 36 | 0 |
| K823338 | COBE HEMOCONCENTRATOR 1.3 | Cobe Laboratories, Inc. | 1983-01-07 | 60 | 0 |
| K823092 | HEMAFLO BLOOD TUBING SETS | Cobe Laboratories, Inc. | 1982-11-22 | 33 | 0 |
| K820694 | COBE PPD 1.3L, #18-520-009 | Cobe Laboratories, Inc. | 1982-03-31 | 19 | 0 |
| K820125 | COBE CENTRY 2000 RX | Cobe Laboratories, Inc. | 1982-03-23 | 64 | 0 |
| K820173 | COBE SINGLE-NEEDLE CONTROLLER #18-756 | Cobe Laboratories, Inc. | 1982-03-23 | 61 | 0 |
| K820237 | COBE ACUFLEX FSN, #15-208 | Cobe Laboratories, Inc. | 1982-03-10 | 41 | 0 |
| K820238 | COBE ACUFLEX SSN, #15-220 | Cobe Laboratories, Inc. | 1982-03-10 | 41 | 0 |
| K812336 | COBE PPD 1.9 | Cobe Laboratories, Inc. | 1981-08-31 | 13 | 0 |
| K812093 | COBE HEAT EXCHANGER RESERVOIR MODULE | Cobe Laboratories, Inc. | 1981-08-13 | 20 | 0 |
| K810066 | COBE PPD .8 | Cobe Laboratories, Inc. | 1981-06-09 | 147 | 0 |
| K810505 | CARDIOPULMONARY BYPASS OXYGENATOR | Cobe Laboratories, Inc. | 1981-04-23 | 58 | 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