Philips Park: FDA clearances and approvals
Philips Park has 11 FDA 510(k) clearances (first 1984, latest 1986), across 3 product codes in 2 review panels. Median 510(k) review time: 83 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 7 | 7 |
| FLL | Continuous Measurement Thermometer | 3 | 3 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
Review panels
- Cardiovascular (8)
- General Hospital (3)
Most recent Philips Park 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K855048 | NORELCO DIGITAL BLOOD PRESSURE METER HC3001 | DXN | 1986-11-17 | 335 |
| K854279 | NORELCO ELECTRONIC DIGITAL BP METER HC3030 | DXN | 1986-11-17 | 389 |
| K855177 | NORELCO ELECTRNIC DIGITAL BLOOD PRESSURE METER | DXN | 1986-11-07 | 316 |
| K854023 | NORELCO ELECTRONIC DIGITAL BP METER HC3501 | DXQ | 1986-03-26 | 177 |
| K854800 | NORELCO DIGITAL THERMOMETER, MODEL HT 960 | FLL | 1986-01-09 | 38 |
| K852128 | NORELCO ELECTRONIC DIGITAL BP METER HC3501 | DXN | 1985-09-12 | 120 |
| K852037 | NORELCO ELECTRONIC DIGITAL BLOOD PRESSURE METER | DXN | 1985-06-11 | 33 |
| K851049 | NORELCO BLOOD PRESSURE METER | DXN | 1985-05-16 | 63 |
| K851075 | NORELCO DIGITAL MODEL 970 THERMOMETER | FLL | 1985-04-04 | 17 |
| K851010 | NORELCO DIGITAL MODEL 987 THERMOMETER | FLL | 1985-04-04 | 23 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Philips Park.
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 Park have?
Philips Park has 11 FDA 510(k) clearances (first 1984, latest 1986), across 3 product codes in 2 review panels.
How long does FDA take to clear Philips Park's 510(k)s?
The median time from FDA receipt to decision across Philips Park's cleared 510(k)s is 83 days.
What devices does Philips Park make?
Its most frequent FDA product codes are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 7); FLL (Continuous Measurement Thermometer, 3); DXQ (Blood Pressure Cuff, 1).
Has Philips Park had device recalls?
openFDA lists no recalls under a recalling firm name matching Philips Park. Related entities may recall under other names.
Next steps
- See all 11 Philips Park clearances with predicates and recalls
- Run predicate analysis for product code DXN, Philips Park'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.