Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Philips Medical Systems, Inc. — Predicate Candidate Screening
111 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
288 days90th percentile
111clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093355 | PCR ELEVA 1.2 | Philips Medical Systems, Inc. | 2010-01-08 | 73 | 0 |
| K090808 | PINNACLE3 SMARTARC | Philips Medical Systems, Inc. | 2009-04-03 | 9 | 1 |
| K071391 | PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142 | Philips Medical Systems, Inc. | 2007-09-07 | 112 | 0 |
| K063783 | PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLI | Philips Medical Systems, Inc. | 2007-04-27 | 127 | 0 |
| K041741 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AN | Philips Medical Systems, Inc. | 2004-07-21 | 23 | 3 |
| K040955 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 A | Philips Medical Systems, Inc. | 2004-05-12 | 29 | 0 |
| K040404 | HEARTSTART MRX, MODEL M3535A | Philips Medical Systems, Inc. | 2004-05-04 | 77 | 8 |
| K040357 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AN | Philips Medical Systems, Inc. | 2004-03-03 | 19 | 0 |
| K032979 | PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AN | Philips Medical Systems, Inc. | 2004-02-20 | 149 | 0 |
| K033715 | PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASU | Philips Medical Systems, Inc. | 2004-02-13 | 79 | 3 |
| K033662 | SYNERGY SPINE ARRAY COIL | Philips Medical Systems, Inc. | 2004-02-02 | 73 | 0 |
| K033326 | PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM | Philips Medical Systems, Inc. | 2003-10-29 | 13 | 75 |
| K032046 | PHILLIPS OMNIDIAGNOST ELEVA | Philips Medical Systems, Inc. | 2003-07-17 | 15 | 6 |
| K031403 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1 | Philips Medical Systems, Inc. | 2003-05-30 | 25 | 0 |
| K030731 | M2376A DEVICELINK SYSTEM | Philips Medical Systems, Inc. | 2003-03-21 | 11 | 0 |
| K030038 | PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH | Philips Medical Systems, Inc. | 2003-03-12 | 65 | 0 |
| K023931 | PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS | Philips Medical Systems, Inc. | 2003-02-24 | 90 | 0 |
| K024042 | PANORAMA ENHANCEMENTS | Philips Medical Systems, Inc. | 2003-02-04 | 60 | 0 |
| K013644 | ACQPLAN 5.0 | Philips Medical Systems, Inc. | 2002-09-12 | 311 | 0 |
| K021912 | M2376 DEVICELINK SYSTEM | Philips Medical Systems, Inc. | 2002-06-24 | 13 | 0 |
| K020708 | PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES | Philips Medical Systems, Inc. | 2002-04-25 | 51 | 2 |
| K020494 | MODIFICATION TO M2376A DEVICELINK SYSTEM | Philips Medical Systems, Inc. | 2002-02-21 | 8 | 0 |
| K014261 | ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0 | Philips Medical Systems, Inc. | 2002-02-12 | 47 | 0 |
| K014159 | PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIP | Philips Medical Systems, Inc. | 2002-01-18 | 30 | 0 |
| K014181 | M2376A DEVICELINK SYSTEM, MODEL M2376A | Philips Medical Systems, Inc. | 2002-01-15 | 26 | 0 |
| K013427 | MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIE | Philips Medical Systems, Inc. | 2001-11-29 | 44 | 0 |
| K013199 | PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMP | Philips Medical Systems, Inc. | 2001-11-28 | 64 | 0 |
| K013470 | MODIFICATION TO M2376A DEVICELINK SYSTEM | Philips Medical Systems, Inc. | 2001-11-14 | 27 | 0 |
| K010762 | PHILIPS BV LIBRA | Philips Medical Systems, Inc. | 2001-04-02 | 19 | 1 |
| K010435 | PHILIPS BV PULSERA/ENDURA | Philips Medical Systems, Inc. | 2001-03-12 | 27 | 10 |
| K994210 | INTURIS SUITE | Philips Medical Systems, Inc. | 2000-02-04 | 52 | 0 |
| K990455 | PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION | Philips Medical Systems, Inc. | 1999-05-12 | 89 | 0 |
| K990423 | PHILIPS NICOL COLLIMATOR FAMILY | Philips Medical Systems, Inc. | 1999-03-15 | 32 | 0 |
| K981480 | PHILIPS EASYGUIDE | Philips Medical Systems, Inc. | 1999-01-28 | 279 | 0 |
| K982795 | PHILIPS BUCKY VISION | Philips Medical Systems, Inc. | 1998-11-24 | 106 | 17 |
| K980820 | PHILIPS EASYGUIDE | Philips Medical Systems, Inc. | 1998-10-13 | 224 | 0 |
| K982631 | PHILIPS TOMOSCAN CS | Philips Medical Systems, Inc. | 1998-10-06 | 70 | 0 |
| K982993 | PHILIPS OMNIDIAGNOST | Philips Medical Systems, Inc. | 1998-09-29 | 33 | 3 |
| K982706 | PHILIPS BV300 SERIES RELEASE 2.1 | Philips Medical Systems, Inc. | 1998-09-02 | 29 | 0 |
| K971965 | PHILIPS EASYVISION | Philips Medical Systems, Inc. | 1998-01-30 | 247 | 0 |
| K973983 | PHILLIPS EASY VISION FAMILY WORKSTATION OPTION ENDO 3D | Philips Medical Systems, Inc. | 1998-01-08 | 80 | 0 |
| K973835 | PHILIPS EASYVISION WORKSTATION | Philips Medical Systems, Inc. | 1998-01-06 | 90 | 0 |
| K963990 | GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE | Philips Medical Systems, Inc. | 1997-05-29 | 237 | 0 |
| K964124 | PHILIPS COMPUTED RADIOGRAPHY | Philips Medical Systems, Inc. | 1996-12-18 | 64 | 2 |
| K963624 | PHILIPS SLI SERIES LINEAR ACCELERATOR | Philips Medical Systems, Inc. | 1996-12-06 | 86 | 2 |
| K961834 | PHILIPS EASYGUIDE NEURO | Philips Medical Systems, Inc. | 1996-11-08 | 179 | 0 |
| K961374 | PHILIPS MULTIDIAGNOST 4 | Philips Medical Systems, Inc. | 1996-08-19 | 132 | 3 |
| K953911 | PHILIPS EASYVISION | Philips Medical Systems, Inc. | 1996-06-27 | 311 | 0 |
| K953095 | PHILIPS EASYVISION | Philips Medical Systems, Inc. | 1995-11-14 | 134 | 0 |
| K953570 | PHILIPS MULTI LEAF PRESCRIPTION ENTRY SYSTEM (MLP) | Philips Medical Systems, Inc. | 1995-10-25 | 86 | 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