Philips Medizin Systeme Boeblingen GmbH: FDA filings under this applicant name
FDA lists 48 510(k) clearances under the applicant name “Philips Medizin Systeme Boeblingen GmbH” (first 2004, latest 2026), across 12 product codes in 3 review panels. Median 510(k) review time under this name: 94 days. Since 2017 the median was 195 days, against 186 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Philips, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 19 |
| 2013 | 2 | 207 |
| 2014 | 0 | — |
| 2015 | 3 | 73 |
| 2016 | 1 | 29 |
| 2017 | 3 | 112 |
| 2018 | 4 | 134 |
| 2019 | 3 | 230 |
| 2020 | 1 | 401 |
| 2021 | 2 | 136 |
| 2022 | 0 | — |
| 2023 | 3 | 264 |
| 2024 | 1 | 258 |
| 2025 | 1 | 186 |
| 2026 | 1 | 162 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Philips Medizin Systeme Boeblingen GmbH took a median 195 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 186 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 25 | 25 |
| HGM | System, Monitoring, Perinatal | 7 | 7 |
| DQA | Oximeter | 3 | 3 |
| DXJ | Display, Cathode-Ray Tube, Medical | 3 | 3 |
| DSI | Detector And Alarm, Arrhythmia | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 1 | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 | 1 |
Plus 2 more product codes.
Review panels
Most recent Philips Medizin Systeme Boeblingen GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) | MHX | 2026-02-06 | 162 |
| K251146 | IntelliVue Patient monitors MX400, MX450, MX500, MX550 | MHX | 2025-10-17 | 186 |
| K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) | HGM | 2024-07-02 | 258 |
| K231671 | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468) | MHX | 2023-12-19 | 194 |
| K230604 | IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) | MHX | 2023-11-22 | 264 |
| K223574 | IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066) | MHX | 2023-08-22 | 265 |
| K210906 | IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4 | MHX | 2021-10-07 | 195 |
| K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X) | DXJ | 2021-09-30 | 77 |
| K192137 | IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 | MHX | 2020-09-11 | 401 |
| K182979 | IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 | MHX | 2019-11-19 | 389 |
38 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Philips Medizin Systeme Boeblingen GmbH.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Philips Medical Systems, Inc. (218 510(k)s)
- Philips Medical Systems (Cleveland), Inc. (190 510(k)s)
- Philips Medical Systems Nederland B.V. (106 510(k)s)
- Philips Medical Systems North America, Inc. (95 510(k)s)
- Philips Ultrasound, Inc. (77 510(k)s)
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (25 510(k)s)
- Philips Health Care (20 510(k)s)
- Philips Hearing Instruments Co. (20 510(k)s)
- Philips Medical Systems Dmc GmbH (18 510(k)s)
- Philips Healthcare (Suzhou) Co., Ltd. (17 510(k)s)
- Philips Medizin Systeme Boblingen GmbH (12 510(k)s)
- Philips Int'L B.V. (11 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Philips Medizin Systeme Boeblingen GmbH?
FDA lists 48 510(k) clearances under the applicant name “Philips Medizin Systeme Boeblingen GmbH” (first 2004, latest 2026), across 12 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Philips Medizin Systeme Boeblingen GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Philips Medizin Systeme Boeblingen GmbH is 94 days. Since 2017: 195 days, versus 186 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Philips Medizin Systeme Boeblingen GmbH?
The most frequent FDA product codes under this applicant name are MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 25); HGM (System, Monitoring, Perinatal, 7); DQA (Oximeter, 3).
Next steps
- See all 48 Philips Medizin Systeme Boeblingen GmbH clearances with predicates and recalls
- Run predicate analysis for product code MHX, Philips Medizin Systeme Boeblingen GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.