Philips Medical Systems, Inc.: FDA clearances and approvals
Philips Medical Systems, Inc. has 218 FDA 510(k) clearances (first 1983, latest 2021), plus 4 PMA decisions, across 55 product codes in 6 review panels. Median 510(k) review time: 74 days. Since 2017 its median was 158 days, against 122 days for all cleared 510(k)s in the same product codes. openFDA lists 179 product recalls by a recalling firm named Philips Medical Systems, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 96 |
| 2013 | 7 | 122 |
| 2014 | 4 | 244 |
| 2015 | 4 | 130 |
| 2016 | 4 | 116 |
| 2017 | 3 | 107 |
| 2018 | 1 | 203 |
| 2019 | 1 | 243 |
| 2020 | 2 | 325 |
| 2021 | 3 | 107 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Philips Medical Systems, Inc.'s cleared 510(k)s took a median 158 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 32 | 32 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 19 | 17 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 16 | 16 |
| LLZ | System, Image Processing, Radiological | 14 | 14 |
| IYE | Accelerator, Linear, Medical | 11 | 11 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 10 | 10 |
| DPS | Electrocardiograph | 9 | 9 |
| DQA | Oximeter | 8 | 8 |
| JAK | System, X-Ray, Tomography, Computed | 8 | 8 |
| IZI | System, X-Ray, Angiographic | 6 | 6 |
Plus 45 more product codes.
Review panels
- Cardiovascular (103)
- Radiology (100)
- Anesthesiology (10)
- Neurology (3)
- Obstetrics and Gynecology (3)
- Gastroenterology and Urology (2)
Most recent Philips Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212704 | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System | IYN | 2021-09-24 | 29 |
| K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | IYN | 2021-09-08 | 107 |
| K210560 | Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph | DPS | 2021-06-30 | 125 |
| K191738 | PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph | DPS | 2020-09-29 | 459 |
| K192875 | Philips Biosensor BX100 | DRG | 2020-04-16 | 191 |
| K183387 | M3290B Patient Information Center iX | MHX | 2019-08-06 | 243 |
| K180017 | MX40 Release C.01 | MHX | 2018-07-24 | 203 |
| K172226 | MX40 Release B.07 | MHX | 2017-11-09 | 107 |
| K163584 | M3290B Philips IntelliVue Information Center iX | MHX | 2017-07-07 | 199 |
| K163649 | SureSigns VS3; SureSigns VS4 | DSJ | 2017-03-31 | 98 |
208 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P180028 | PMA | HeartStart FRx Defibrillator | 2020-05-11 |
| P160028 | PMA | Philips HeartStart FR3 Defibrillator | 2020-05-11 |
| P160029 | PMA | HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) | 2019-06-06 |
| P020028 | PMA | SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING | 2003-01-03 |
Recalls
179 product recalls in 102 recall events; 11 initiated in the last five years. Most recent: 2026-06-11.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Philips Medical Systems, Inc.'s product codes (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
Frequently asked questions
How many FDA 510(k) clearances does Philips Medical Systems, Inc. have?
Philips Medical Systems, Inc. has 218 FDA 510(k) clearances (first 1983, latest 2021), plus 4 PMA decisions, across 55 product codes in 6 review panels.
How long does FDA take to clear Philips Medical Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Philips Medical Systems, Inc.'s cleared 510(k)s is 74 days. Since 2017: 158 days, versus 122 days for all cleared 510(k)s in the same product codes.
What devices does Philips Medical Systems, Inc. make?
Its most frequent FDA product codes are MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 32); MKJ (Automated External Defibrillators (Non-Wearable), 19); LNH (System, Nuclear Magnetic Resonance Imaging, 16).
Has Philips Medical Systems, Inc. had device recalls?
openFDA lists 179 product recalls in 102 recall events by a recalling firm whose name matches Philips Medical Systems, Inc; the most recent began 2026-06-11. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 218 Philips Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MHX, Philips Medical Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.