Philips Medizin Systeme Böblingen GmbH: FDA clearances and approvals
Philips Medizin Systeme Böblingen GmbH has 10 FDA 510(k) clearances (first 2022, latest 2026), across 6 product codes in 2 review panels. Median 510(k) review time: 211 days. Since 2017 its median was 211 days, against 196 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 256 |
| 2023 | 1 | 270 |
| 2024 | 1 | 200 |
| 2025 | 5 | 196 |
| 2026 | 2 | 198 |
Review time against the same product codes
Since 2017, Philips Medizin Systeme Böblingen GmbH's cleared 510(k)s took a median 211 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 196 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 5 | 5 |
| DPS | Electrocardiograph | 1 | 1 |
| DQA | Oximeter | 1 | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 1 | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 1 | 1 |
Review panels
- Cardiovascular (9)
- Anesthesiology (1)
Most recent Philips Medizin Systeme Böblingen GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) | DQA | 2026-05-29 | 267 |
| K253654 | IntelliVue Measurement Rack 6000 (867317) | MSX | 2026-03-30 | 130 |
| K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) | MHX | 2025-11-10 | 161 |
| K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) | MHX | 2025-09-02 | 196 |
| K242962 | Telemetry Monitor 5500 Release 4.0 (867232) | MHX | 2025-05-05 | 222 |
| K241890 | Philips Holter Analysis System | MLO | 2025-03-21 | 266 |
| K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn | DSA | 2025-01-17 | 63 |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000) | DPS | 2024-12-17 | 200 |
| K221348 | IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) | MHX | 2023-02-03 | 270 |
| K211900 | Patient Information Center iX | MHX | 2022-03-04 | 256 |
Recalls
openFDA lists no recalls under a recalling firm named Philips Medizin Systeme Böblingen GmbH.
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.
Frequently asked questions
How many FDA 510(k) clearances does Philips Medizin Systeme Böblingen GmbH have?
Philips Medizin Systeme Böblingen GmbH has 10 FDA 510(k) clearances (first 2022, latest 2026), across 6 product codes in 2 review panels.
How long does FDA take to clear Philips Medizin Systeme Böblingen GmbH's 510(k)s?
The median time from FDA receipt to decision across Philips Medizin Systeme Böblingen GmbH's cleared 510(k)s is 211 days. Since 2017: 211 days, versus 196 days for all cleared 510(k)s in the same product codes.
What devices does Philips Medizin Systeme Böblingen GmbH make?
Its most frequent FDA product codes are MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 5); DPS (Electrocardiograph, 1); DQA (Oximeter, 1).
Has Philips Medizin Systeme Böblingen GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Philips Medizin Systeme Böblingen GmbH. Related entities may recall under other names.
Next steps
- See all 10 Philips Medizin Systeme Böblingen GmbH clearances with predicates and recalls
- Run predicate analysis for product code MHX, Philips Medizin Systeme Böblingen GmbH'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.