Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DRQ — Predicate Candidate Screening
27 FDA 510(k) clearances under this product code; the 50 most recent screened below.
43 daysmedian FDA review time
144 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172216 | ACIST RXi Mini System | Acist Medical Systems, Inc. | 2017-08-18 | 25 | 0 |
| K152693 | CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 8 | Boston Scientific Corporation | 2015-10-21 | 30 | 0 |
| K150235 | CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, | Boston Scientific Corporation | 2015-04-22 | 79 | 1 |
| K050006 | BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VE | C.R. Bard, Inc. | 2005-05-27 | 144 | 0 |
| K050974 | DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTO | Draeger Medical Systems, Inc. | 2005-04-29 | 11 | 0 |
| K033807 | INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROT | Draeger Medical Systems, Inc. | 2004-03-09 | 92 | 0 |
| K013205 | MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 | Millar Instruments, Inc. | 2002-07-02 | 280 | 0 |
| K020277 | SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER | Siemens Medical Solutions USA, Inc. | 2002-02-19 | 22 | 0 |
| K010640 | SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER | Siemens Medical Solutions USA, Inc. | 2001-03-20 | 15 | 0 |
| K913875 | BARD(R) BIOPOTENTIAL AMPLIFIER II | Bard Electrophysiology | 1991-11-27 | 90 | 0 |
| K913110 | PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED | Microwave Medical Systems, Inc. | 1991-10-10 | 90 | 0 |
| K910905 | SFA-II MICROPROCESSOR-CONTROLLED MODULE | Life Sciences Manufacturing, Inc. | 1991-07-24 | 141 | 0 |
| K904749 | TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 | Transtracheal Systems | 1991-03-01 | 133 | 0 |
| K901358 | BARD BIOPOTENTIAL AMPLIFIER II | C.R. Bard, Inc. | 1990-05-09 | 47 | 0 |
| K894295 | ASTRO-MED ASC-951 PRESSURE PROCESSOR | Astro-Med, Inc. | 1990-01-18 | 209 | 0 |
| K885252 | MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001 | Ep Technologies, Inc. | 1989-01-13 | 30 | 0 |
| K870783 | BPA CARDIOVASCULAR PRESSURE AMPLIFIER | Fisher Imaging Corp. | 1987-04-27 | 60 | 0 |
| K870728 | TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701 | A&D Engineering, Inc. | 1987-03-27 | 31 | 0 |
| K864320 | SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE | Cordis Corp. | 1987-02-20 | 109 | 0 |
| K830914 | EXTERNAL VALVE FUNCTION BLOCK | Honeywell, Inc. | 1983-08-12 | 141 | 0 |
| K803011 | DISPOSABLE DIAPHRAGM DONE | Sorensen Research | 1980-12-31 | 33 | 0 |
| K802961 | TRANSDUCER DOME, CAT.#SD-101 | Sorensen Research | 1980-12-31 | 40 | 0 |
| K800488 | SURGERY DISPLAY SYSTEM | Kent Barker & Assoc. | 1980-04-16 | 43 | 0 |
| K792190 | MODEL CF-300 THREE CHANNEL FLOW METER | Wilton Webster Laboratories | 1979-11-21 | 21 | 0 |
| K780571 | BLOOD PRESSURE MODULE | C-V Monitors Corp. | 1978-05-09 | 29 | 0 |
| K770247 | D.C. AMPLIFIER MODULE | Mennen Greatbatch Electonics | 1977-02-14 | 7 | 0 |
| K761017 | PRESSURE MODULE (MODEL P3) | Datascope Corp. | 1976-11-15 | 5 | 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