Philips Medizinsysteme Boeblingen GmbH, Cardiac AN: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Philips Medizinsysteme Boeblingen GmbH, Cardiac AN” (first 2007, latest 2014), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 84 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 | 2 | 142 |
| 2013 | 3 | 80 |
| 2014 | 2 | 136 |
| 2015 | 0 | — |
| 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) | 15 | 15 |
| DSI | Detector And Alarm, Arrhythmia | 3 | 3 |
| DQA | Oximeter | 2 | 2 |
| HGM | System, Monitoring, Perinatal | 2 | 2 |
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
| DXJ | Display, Cathode-Ray Tube, Medical | 1 | 1 |
| LKD | Monitor, Carbon-Dioxide, Cutaneous | 1 | 1 |
Review panels
Most recent Philips Medizinsysteme Boeblingen GmbH, Cardiac AN 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141015 | INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT | MHX | 2014-05-19 | 28 |
| K132320 | INTELLIVUE CL RESPIRATION POD | BZQ | 2014-03-26 | 244 |
| K131872 | INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550 | MHX | 2013-10-17 | 115 |
| K131829 | INTELLIVUE PATIENT MONITOR | MHX | 2013-08-16 | 57 |
| K130849 | INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450 | MHX | 2013-06-14 | 80 |
| K120366 | INTELLIVUE PATIENT MONITOR | MHX | 2012-07-18 | 163 |
| K113441 | PHYSIOLOGICAL MONITOR, PATIENT MONITOR | MHX | 2012-03-22 | 122 |
| K111905 | INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216 | DXJ | 2011-10-04 | 91 |
| K110474 | PHILIPS INTELLIVUE TCG10 | LKD | 2011-09-30 | 224 |
| K111083 | PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 | HGM | 2011-08-17 | 120 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Philips Medizinsysteme Boeblingen GmbH, Cardiac AN.
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 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 Medizinsysteme Boeblingen GmbH, Cardiac AN?
FDA lists 25 510(k) clearances under the applicant name “Philips Medizinsysteme Boeblingen GmbH, Cardiac AN” (first 2007, latest 2014), across 7 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 Medizinsysteme Boeblingen GmbH, Cardiac AN?
The median time from FDA receipt to decision across 510(k)s cleared under the name Philips Medizinsysteme Boeblingen GmbH, Cardiac AN is 84 days.
Which FDA product codes appear under Philips Medizinsysteme Boeblingen GmbH, Cardiac AN?
The most frequent FDA product codes under this applicant name are MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 15); DSI (Detector And Alarm, Arrhythmia, 3); DQA (Oximeter, 2).
Next steps
- See all 25 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN clearances with predicates and recalls
- Run predicate analysis for product code MHX, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN'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.