Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CBT — Predicate Candidate Screening
58 FDA 510(k) clearances under this product code; the 50 most recent screened below.
58 daysmedian FDA review time
177 days90th percentile
58clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071269 | HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM | Smiths Medical Asd, Inc. | 2007-08-01 | 86 | 0 |
| K070340 | SECURE ARTERIAL BLOOD SAMPLING SYSTEM | Smiths Medical Asd, Inc. | 2007-03-15 | 37 | 0 |
| K955663 | ABC IN-LINE BLOOD SAMPLING KIT | Utah Medical Products, Inc. | 1997-03-17 | 460 | 0 |
| K954015 | ABG POINT LOK NEEDLE PROTECTION DEVICE | Devon Industries, Inc. | 1995-11-20 | 87 | 3 |
| K954035 | ACTI-FLEX ARTERIAL EXTENSION SET | R-Group Intl. | 1995-09-25 | 28 | 0 |
| K950098 | NEEDLE SAFETY COVER | Hammer-Plane, Inc. | 1995-08-11 | 213 | 0 |
| K945719 | ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM | Sherwood Medical Co. | 1995-03-16 | 115 | 0 |
| K944941 | PISTON SYRINGE | Martell Medical Products, Inc. | 1994-12-05 | 59 | 1 |
| K945485 | ABG NEEDLE PROTECTION | Devon Industries, Inc. | 1994-11-29 | 21 | 0 |
| K940575 | ASPIR-PULSE(TM) SAF-T-VENT | Sherwood Medical Co. | 1994-03-22 | 43 | 0 |
| K931873 | VACVENT | Steven Frank Mercereau | 1993-12-30 | 260 | 0 |
| K930986 | BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560 | Customed, Inc. | 1993-07-14 | 139 | 0 |
| K925453 | SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT I | Sherwood Medical Co. | 1993-07-12 | 257 | 0 |
| K930471 | SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT II | Sherwood Medical Co. | 1993-06-22 | 145 | 0 |
| K930286 | DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS | Concord/Portex | 1993-06-22 | 152 | 0 |
| K914778 | NEOLINE(TM) | Martech Medical Products, Inc. | 1992-09-16 | 329 | 0 |
| K912043 | ACCU-VENT(TM) WITH NEEDLE-PRO(TM) | Concord/Portex | 1991-07-05 | 58 | 0 |
| K905464 | MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING | Angiosystems, Inc. | 1991-05-31 | 177 | 0 |
| K902881 | LAB-SITE SAFETY NEEDLE | Migada, Ltd. | 1990-09-26 | 86 | 0 |
| K902632 | GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS | Marquest Medical Products, Inc. | 1990-09-04 | 82 | 0 |
| K900302 | UMBILICAL CORD BLOOD SAMPLING KIT | Ge Medical Systems Information Technologies | 1990-04-10 | 78 | 0 |
| K897133 | MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT | Transidyne General Corp. | 1990-03-30 | 93 | 0 |
| K895171 | BLOOD GAS SAFETY SYRINGE | Kronner Medical | 1989-11-07 | 89 | 0 |
| K875117 | CIBA CORNING BALANCED HEPARIN FOR CA++ | Ciba Corning Diagnostics Corp. | 1988-02-29 | 76 | 0 |
| K872244 | CORD-ASSURE UMBILICAL BLOOD GAS KIT | Lake Medical Products, Inc. | 1987-07-21 | 40 | 0 |
| K870720 | AIRLIFE ARTERIAL BLOOD GAS SAMPLING SYRINGE | American Pharmaseal Div. Ahsc | 1987-03-17 | 25 | 0 |
| K844615 | BIOSAMPLER | Biotek-Caribbean | 1985-03-21 | 114 | 0 |
| K843360 | ARTAP ARTERIAL BLOOD SAMPLING DEVICE | Analytical Products, Inc. | 1984-10-31 | 64 | 0 |
| K842008 | MARQUEST MICRO STIK 9000 SERIES | Marquest Medical Products, Inc. | 1984-05-25 | 8 | 0 |
| K841486 | ARTERIAL BLOOD SAMPLING KITS | Concord Laboratories, Inc. | 1984-05-23 | 43 | 0 |
| K840986 | PREFILLED PULSATOR SYRINGE | Concord Laboratories, Inc. | 1984-04-05 | 29 | 0 |
| K840987 | VAPORIZED HEPARIN | Concord Laboratories, Inc. | 1984-04-05 | 29 | 0 |
| K833923 | MARZ-175 ARTERIAL BLOOD GAS SYRINGE | Chesebrough-Pond'S U.S.A. Co. | 1984-01-09 | 56 | 0 |
| K833582 | PULSATOR ARTERIAL BLOOD SAMPLING SYRIN | Concord Laboratories, Inc. | 1983-12-27 | 76 | 0 |
| K832545 | ARTERIAL BLOOD SAMPLING KIT | Dhd Medical Products Div. Diemolding Corp. | 1983-09-26 | 59 | 0 |
| K830311 | AUTO STIK | Marquest Medical Products, Inc. | 1983-05-25 | 119 | 0 |
| K830310 | OMNISTICK | Marquest Medical Products, Inc. | 1983-05-25 | 119 | 0 |
| K830312 | ASPIRATOR | Marquest Medical Products, Inc. | 1983-05-25 | 119 | 0 |
| K831034 | QUALISTICK ARTERIAL BLOOD SAMPLER | Radiometer America, Inc. | 1983-05-18 | 48 | 0 |
| K830333 | ABG KITS - CMS 4000 SERIES | Currie Medical Specialties, Inc. | 1983-03-31 | 58 | 0 |
| K822786 | MDM ARTERIAL BLOOD GAS KIT | Martell Medical Products, Inc. | 1982-10-21 | 36 | 0 |
| K822248 | DESERET ARTERIAL BLOOD SAMPLING KIT | Warner-Lambert Co. | 1982-10-21 | 84 | 0 |
| K821406 | ARTERIAL BLOOD SAMPLING KIT | Dhd Medical Products Div. Diemolding Corp. | 1982-06-25 | 45 | 0 |
| K820875 | AUTOSTIK | Marquest Medical Products, Inc. | 1982-05-07 | 39 | 0 |
| K812338 | PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY | Terumo Medical Corp. | 1981-09-23 | 36 | 0 |
| K811860 | EASY-FLO ARTERIAL BLOOD GAS KIT | Dhd Medical Products Div. Diemolding Corp. | 1981-07-16 | 15 | 0 |
| K811199 | MARZ-175 | Emde Corp. | 1981-05-21 | 21 | 0 |
| K801620 | ASPIRATOR | Marquest Medical Products, Inc. | 1980-07-21 | 6 | 0 |
| K801435 | ORGANON ARTERIAL BLOOD SAMPLER | Akzona, Inc. | 1980-07-18 | 29 | 0 |
| K801146 | SAMPLING KIT | Pharmaseal Laboratories | 1980-06-04 | 22 | 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