North American Philips Corp.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “North American Philips Corp.” (first 1981, latest 1984), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 49 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 | 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 | 8 | 8 |
| FLL | Continuous Measurement Thermometer | 2 | 2 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| IOB | Lamp, Infrared, Non Heating | 1 | 1 |
| IRO | Vibrator, Therapeutic | 1 | 1 |
| ISA | Massager, Therapeutic, Electric | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (9)
- Physical Medicine (3)
- General Hospital (2)
Most recent North American Philips Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K842486 | ELECTRONIC DIGITAL BP METER HC 3001 | DXN | 1984-08-24 | 59 |
| K841489 | NORELCO ELECTRONIC DIGITAL BP METER | — | 1984-04-10 | 0 |
| K833755 | ELECTRONIC DIGITAL FEVER THERMOMETER | FLL | 1984-01-30 | 96 |
| K830715 | NORELCO VIBRATING BOARD V900 | IRO | 1983-05-25 | 77 |
| K830687 | NORELCO ELECTRONIC ANALOG BLOOD PRESS | DXN | 1983-05-18 | 75 |
| K830686 | ANEROID BLOOD PRESSURE CUFF #HC1400 | DXN | 1983-05-18 | 75 |
| K830685 | NORELCO DELUXE DIGITAL BLOOD PRESSURE | DXN | 1983-05-18 | 75 |
| K830684 | NORELCO ELECTRONIC DIGITAL BLOOD PRESS | DXN | 1983-05-18 | 75 |
| K813451 | UVA FLUORESCENT TANNING LAMPS | IOB | 1982-01-28 | 49 |
| K811891 | NORELCO MASSAGER PLUS HEAT BELT | ISA | 1981-07-20 | 19 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named North American Philips Corp..
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.
- North American Instrument Corp. (28 510(k)s)
- North American Sterilization & Packaging Co. (16 510(k)s)
- North Pacific Dental, Inc. (11 510(k)s)
- North East Monitoring, Inc. (10 510(k)s)
- North American Technical Services Corp. (9 510(k)s)
- North American Biologicals, Inc. (6 510(k)s)
- North American Medical Products, Inc. (6 510(k)s)
- North American Science Assoc., Inc. (6 510(k)s)
- North Coast Medi-Tek (6 510(k)s)
- North American Alloys, Inc. (5 510(k)s)
- North American Scientific, Inc. (4 510(k)s)
- North Eos Industries, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under North American Philips Corp.?
FDA lists 15 510(k) clearances under the applicant name “North American Philips Corp.” (first 1981, latest 1984), 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 North American Philips Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name North American Philips Corp. is 49 days.
Which FDA product codes appear under North American Philips Corp.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 8); FLL (Continuous Measurement Thermometer, 2); DXQ (Blood Pressure Cuff, 1).
Next steps
- See all 15 North American Philips Corp. clearances with predicates and recalls
- Run predicate analysis for product code DXN, North American Philips Corp.'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.