Philips Medizin Systeme Boblingen GmbH: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Philips Medizin Systeme Boblingen GmbH” (first 2001, latest 2015), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 36 days. 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 | 101 |
| 2013 | 0 | — |
| 2014 | 1 | 266 |
| 2015 | 1 | 117 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 6 | 6 |
| HGM | System, Monitoring, Perinatal | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
| DXJ | Display, Cathode-Ray Tube, Medical | 1 | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 1 | 1 |
Review panels
Most recent Philips Medizin Systeme Boblingen GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151736 | Philips IntelliVue GuardianSoftware | DXJ | 2015-10-21 | 117 |
| K140535 | PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 | HGM | 2014-11-25 | 266 |
| K113657 | INTELLIVUE PATIENT MONITOR | MHX | 2012-03-22 | 101 |
| K102958 | PHILIPS AVALON FETAL MONITOR | HGM | 2011-03-18 | 165 |
| K102562 | INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800 | MHX | 2010-10-21 | 44 |
| K090360 | PHILIPS M3001A MULTI MEASUREMENT SERVER | DQA | 2009-05-04 | 81 |
| K083228 | PHILIPS INTELLIVUE MP5 PATIENT MONITOR | MHX | 2008-11-24 | 21 |
| K060541 | THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS | MHX | 2006-03-24 | 23 |
| K042845 | THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS | MSX | 2004-11-12 | 28 |
| K032858 | THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O. | DSI | 2003-10-10 | 28 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Philips Medizin Systeme Boblingen 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 Medizin Systeme Boeblingen GmbH (48 510(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 Int'L B.V. (11 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Philips Medizin Systeme Boblingen GmbH?
FDA lists 12 510(k) clearances under the applicant name “Philips Medizin Systeme Boblingen GmbH” (first 2001, latest 2015), across 6 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 Boblingen GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Philips Medizin Systeme Boblingen GmbH is 36 days.
Which FDA product codes appear under Philips Medizin Systeme Boblingen GmbH?
The most frequent FDA product codes under this applicant name are MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 6); HGM (System, Monitoring, Perinatal, 2); DQA (Oximeter, 1).
Next steps
- See all 12 Philips Medizin Systeme Boblingen GmbH clearances with predicates and recalls
- Run predicate analysis for product code MHX, Philips Medizin Systeme Boblingen 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.