Philips Hearing Instruments Co.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Philips Hearing Instruments Co.” (first 1991, latest 1997), across 1 product code in 1 review panel. Median 510(k) review time under this name: 28 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 20 | 20 |
Review panels
- Ear, Nose and Throat (20)
Most recent Philips Hearing Instruments Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972818 | D72 DIGITAL | ESD | 1997-10-17 | 80 |
| K971804 | PHILIPS S1694, S1695 | ESD | 1997-06-06 | 23 |
| K965088 | M11 SERIES: M11, M11M | ESD | 1997-01-24 | 36 |
| K961770 | PHILIPS 71 SERIES | ESD | 1996-08-02 | 86 |
| K952658 | HEARING AID | ESD | 1995-07-28 | 46 |
| K944404 | MO4 SERIES | ESD | 1994-12-27 | 110 |
| K943670 | MO6 SERIES | ESD | 1994-08-18 | 23 |
| K943395 | PHILIPS M38 SERIES | ESD | 1994-08-09 | 26 |
| K942164 | PHILIPS 61 SERIES | ESD | 1994-06-17 | 44 |
| K933850 | PHILIPS 45 SERIES | ESD | 1993-09-07 | 32 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Philips Hearing Instruments Co..
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 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 Hearing Instruments Co.?
FDA lists 20 510(k) clearances under the applicant name “Philips Hearing Instruments Co.” (first 1991, latest 1997), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Philips Hearing Instruments Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Philips Hearing Instruments Co. is 28 days.
Which FDA product codes appear under Philips Hearing Instruments Co.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 20).
Next steps
- See all 20 Philips Hearing Instruments Co. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Philips Hearing Instruments Co.'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.