Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DSK — Predicate Candidate Screening
77 FDA 510(k) clearances under this product code; the 50 most recent screened below.
73 daysmedian FDA review time
231 days90th percentile
77clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231586 | Endophys Blood Pressure Monitor model BPM-30 | Endophys Technologies, LLC | 2023-11-03 | 156 | 0 |
| K160945 | Endophys Blood Pressure Monitor | Endophys Holdings, LLC | 2016-09-26 | 174 | 0 |
| K152582 | CORE FM System, Patient Interface Module (OPIM), Hemodynamic | Volcano Corporation | 2015-12-03 | 84 | 0 |
| K141615 | ENDOPHYS BLOOD PRESSURE MONITOR | Endophys, Inc. | 2015-01-07 | 205 | 0 |
| K080670 | MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM | Atcor Medical | 2008-04-23 | 44 | 0 |
| K070795 | SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM | Atcor Medical Pty, Ltd. | 2007-08-31 | 162 | 0 |
| K033738 | MONITORING SYSTEM, MODEL ARGUS PB-2200 | Schiller AG | 2004-08-24 | 270 | 0 |
| K021517 | ABP FOR WINDOWS | Rozinn Electronics, Inc. | 2002-07-24 | 75 | 0 |
| K013943 | RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), | Radi Medical Systems AB | 2001-12-18 | 19 | 0 |
| K011865 | ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTIO | Zoll Medical Corp | 2001-07-31 | 47 | 0 |
| K003122 | SMARTFLOW, MODEL SFIP 2000 | Florence Medical , Ltd. | 2001-05-14 | 221 | 0 |
| K002742 | SPHYGMOCOR MX MODEL SCOR-MX | Pwv Medical Pty, Lt. | 2001-05-01 | 242 | 0 |
| K002067 | RADIANALYZER, MODEL 12710 | Radi Medical Systems AB | 2001-01-11 | 188 | 0 |
| K983250 | INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS | Magnetic Resonance Equipment Corp. | 1999-12-12 | 452 | 1 |
| K951226 | VITALMAX 4000/MINIPACK 3100/3000 | Pace Tech, Inc. | 1996-11-21 | 612 | 0 |
| K943457 | AS/3 PRESSURE TEMPERATURE MODULE, M-PT | Datex Division Instrumentarium Corp. | 1994-07-27 | 9 | 0 |
| K921388 | BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE | Biochem International, Inc. | 1993-05-26 | 429 | 0 |
| K925899 | AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01 | Welch Allyn, Inc. | 1993-05-21 | 182 | 0 |
| K914273 | A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR | A&D Engineering, Inc. | 1993-02-09 | 504 | 0 |
| K912816 | PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE | S & W Medico Teknik | 1992-04-10 | 297 | 0 |
| K912833 | CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY | Camino Laboratories, Inc. | 1991-09-23 | 89 | 0 |
| K903900 | SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD. | Ppg Hellige B.V. | 1991-01-08 | 138 | 0 |
| K901514 | XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS. | Ppg Industries, Inc. | 1990-11-16 | 231 | 0 |
| K896535 | MEDILOG OPTIMA | Oxford Medilog, Inc. | 1990-01-18 | 65 | 0 |
| K893232 | MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM | Camino Laboratories, Inc. | 1989-07-14 | 77 | 0 |
| K884118 | TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA | S & W Medico Teknik | 1989-04-25 | 207 | 0 |
| K884938 | VITAL SIGNS MONITOR | Tico Medical Instruments, Inc. | 1989-04-19 | 142 | 0 |
| K885235 | SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. | Spectramed, Inc. | 1989-01-25 | 36 | 1 |
| K882093 | CARDIOCAP(TM) CMO-104 MONITOR | Datex Division Instrumentarium Corp. | 1988-07-28 | 70 | 0 |
| K882085 | PROPAQ 104(TM) | Protocol Systems, Inc. | 1988-07-28 | 71 | 0 |
| K880079 | TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420 | A&D Engineering, Inc. | 1988-03-31 | 80 | 0 |
| K874338 | TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2610 | A&D Engineering, Inc. | 1988-02-05 | 107 | 0 |
| K874339 | TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2620 | A&D Engineering, Inc. | 1987-12-18 | 58 | 0 |
| K873765 | FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER | Nam Tai , Ltd. | 1987-10-09 | 23 | 0 |
| K871720 | MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETER | A&D Engineering, Inc. | 1987-07-29 | 86 | 0 |
| K871718 | MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER | A&D Engineering, Inc. | 1987-06-24 | 51 | 0 |
| K863042 | SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR | Siemens Medical Solutions USA, Inc. | 1987-01-14 | 155 | 0 |
| K862200 | FORTEC MI-100, BLOOD PRESSURE METER | Fortec Electronic Corp./Nam Tai | 1986-11-18 | 161 | 0 |
| K862455 | MODIFIED CARDIOCAP MONITOR | Datex Division Instrumentarium Corp. | 1986-09-24 | 89 | 0 |
| K862647 | PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403 | Ivy Biomedical Systems, Inc. | 1986-08-18 | 38 | 0 |
| K860689 | SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE | Spacelabs, Inc. | 1986-07-30 | 155 | 0 |
| K850879 | HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR | Mennen Medical, Inc. | 1985-04-25 | 52 | 0 |
| K844397 | POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000 | Associated Mills, Inc. | 1985-04-18 | 156 | 0 |
| K844396 | POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000 | Associated Mills, Inc. | 1985-04-18 | 156 | 0 |
| K832017 | LME BLOOD PRESSURE MONITOR | Litton Medical Electronics | 1983-10-31 | 130 | 0 |
| K831481 | DIXIE USA PTL, PHARYNGEAL TRACHEAL LUMEN | Eugene Scarberry | 1983-10-04 | 148 | 0 |
| K822843 | HTS *1 | Global Office Automation System, Inc. | 1982-12-15 | 83 | 0 |
| K822878 | MODEL 78553A PRESSURE PLUG-IN MODULE | Hewlett-Packard Co. | 1982-10-18 | 21 | 0 |
| K811147 | VITA-STAT MODEL 9000-A | Vita-Stat | 1981-06-30 | 64 | 0 |
| K811148 | VITA-STAT MODEL 9000-S | Viat-Stat | 1981-06-30 | 64 | 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