Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Philips Hearing Instruments Co. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
110 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972818 | D72 DIGITAL | Philips Hearing Instruments Co. | 1997-10-17 | 80 | 0 |
| K971804 | PHILIPS S1694, S1695 | Philips Hearing Instruments Co. | 1997-06-06 | 23 | 0 |
| K965088 | M11 SERIES: M11, M11M | Philips Hearing Instruments Co. | 1997-01-24 | 36 | 0 |
| K961770 | PHILIPS 71 SERIES | Philips Hearing Instruments Co. | 1996-08-02 | 86 | 0 |
| K952658 | HEARING AID | Philips Hearing Instruments Co. | 1995-07-28 | 46 | 0 |
| K944404 | MO4 SERIES | Philips Hearing Instruments Co. | 1994-12-27 | 110 | 0 |
| K943670 | MO6 SERIES | Philips Hearing Instruments Co. | 1994-08-18 | 23 | 0 |
| K943395 | PHILIPS M38 SERIES | Philips Hearing Instruments Co. | 1994-08-09 | 26 | 0 |
| K942164 | PHILIPS 61 SERIES | Philips Hearing Instruments Co. | 1994-06-17 | 44 | 0 |
| K933850 | PHILIPS 45 SERIES | Philips Hearing Instruments Co. | 1993-09-07 | 32 | 0 |
| K921725 | PHILIP XP SERIES, IN-THE CANAL HEARING AID | Philips Hearing Instruments Co. | 1992-08-11 | 124 | 0 |
| K921463 | PHILIPS 31 SERIES IN THE EAR HEARING AID | Philips Hearing Instruments Co. | 1992-05-22 | 56 | 0 |
| K915252 | PHILIPS P74P BEHIND-THE-EAR HEARING AID | Philips Hearing Instruments Co. | 1991-12-05 | 17 | 0 |
| K914800 | P54 BTE HEARING AID | Philips Hearing Instruments Co. | 1991-11-05 | 13 | 0 |
| K913389 | PHILIPS S1594 OTB HEARING AID | Philips Hearing Instruments Co. | 1991-08-26 | 28 | 0 |
| K913390 | M32 IN-THE-EAR HEARING AID | Philips Hearing Instruments Co. | 1991-08-26 | 28 | 0 |
| K912339 | PHILIPS M30 IN-THE-EAR HEARING AID | Philips Hearing Instruments Co. | 1991-06-07 | 14 | 0 |
| K910744 | PHILIPS MODEL S46-O BTE HEARING AID | Philips Hearing Instruments Co. | 1991-02-28 | 7 | 0 |
| K910743 | PHILIPS MODEL S46-OL BTE HEARING AID | Philips Hearing Instruments Co. | 1991-02-28 | 7 | 0 |
| K910206 | PHILIPS MODEL S47 BTE HEARING AID | Philips Hearing Instruments Co. | 1991-02-05 | 20 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda