Philips Int'L B.V.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Philips Int'L B.V.” (first 1985, latest 1992), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 15 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 |
|---|---|---|---|
| FTC | Light, Ultraviolet, Dermatological | 9 | 9 |
| ESD | Hearing Aid, Air-Conduction, Prescription | 2 | 2 |
Review panels
Most recent Philips Int'L B.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K920134 | PHILIPS 41 SERIES RAINBOW | ESD | 1992-01-24 | 11 |
| K920142 | PHILIPS M60 SERIES | ESD | 1992-01-23 | 10 |
| K852348 | PHILIPS SOLARIUM HP 3134 | FTC | 1985-06-27 | 27 |
| K851536 | PHILIPS UV-A SOLARIUM TYPE HP 3141 | FTC | 1985-05-01 | 15 |
| K851535 | PHILIPS UV-A SOLARIUM TYPE HP 3140 | FTC | 1985-05-01 | 15 |
| K851534 | PHILIPS UV-A SOLARIUM TYPE HP 3150 | FTC | 1985-05-01 | 15 |
| K851533 | PHILIPS UV-A SDARIUM TYPE HP 3148(CFR 21 SUNLAMP | FTC | 1985-05-01 | 15 |
| K850206 | PHILIPS UV-A SOLARIUM TYPE HP 3126-SUNLAMP | FTC | 1985-02-21 | 34 |
| K850205 | PHILIPS UV-A SOLARIUM TYPE HP 3127-SUNLAMP | FTC | 1985-02-21 | 34 |
| K850204 | PHILIPS UV-A SOLARIUM TYPE HP 3130-SUNLAMP | FTC | 1985-02-21 | 34 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Philips Int'L B.V..
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 Medizin Systeme Boblingen GmbH (12 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Philips Int'L B.V.?
FDA lists 11 510(k) clearances under the applicant name “Philips Int'L B.V.” (first 1985, latest 1992), across 2 product codes in 2 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 Int'L B.V.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Philips Int'L B.V. is 15 days.
Which FDA product codes appear under Philips Int'L B.V.?
The most frequent FDA product codes under this applicant name are FTC (Light, Ultraviolet, Dermatological, 9); ESD (Hearing Aid, Air-Conduction, Prescription, 2).
Next steps
- See all 11 Philips Int'L B.V. clearances with predicates and recalls
- Run predicate analysis for product code FTC, Philips Int'L B.V.'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.