Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
North American Philips Corp. · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
77 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K842486 | ELECTRONIC DIGITAL BP METER HC 3001 | North American Philips Corp. | 1984-08-24 | 59 | 0 |
| K841489 | NORELCO ELECTRONIC DIGITAL BP METER | North American Philips Corp. | 1984-04-10 | 0 | 0 |
| K833755 | ELECTRONIC DIGITAL FEVER THERMOMETER | North American Philips Corp. | 1984-01-30 | 96 | 0 |
| K830715 | NORELCO VIBRATING BOARD V900 | North American Philips Corp. | 1983-05-25 | 77 | 0 |
| K830686 | ANEROID BLOOD PRESSURE CUFF #HC1400 | North American Philips Corp. | 1983-05-18 | 75 | 0 |
| K830684 | NORELCO ELECTRONIC DIGITAL BLOOD PRESS | North American Philips Corp. | 1983-05-18 | 75 | 0 |
| K830685 | NORELCO DELUXE DIGITAL BLOOD PRESSURE | North American Philips Corp. | 1983-05-18 | 75 | 0 |
| K830687 | NORELCO ELECTRONIC ANALOG BLOOD PRESS | North American Philips Corp. | 1983-05-18 | 75 | 0 |
| K813451 | UVA FLUORESCENT TANNING LAMPS | North American Philips Corp. | 1982-01-28 | 49 | 0 |
| K811891 | NORELCO MASSAGER PLUS HEAT BELT | North American Philips Corp. | 1981-07-20 | 19 | 0 |
| K811634 | NORELCO ANEROID BLOOD PRESSURE METER | North American Philips Corp. | 1981-06-30 | 20 | 0 |
| K811635 | NORELCO DIGITAL BLOOD PRESSURE METER | North American Philips Corp. | 1981-06-30 | 20 | 0 |
| K811636 | NORELCO ELECTRONIC BLOOD PRESSURE METER | North American Philips Corp. | 1981-06-30 | 20 | 0 |
| K811672 | NORELCO ELECTRONIC DIGITAL THERMOMETER | North American Philips Corp. | 1981-06-26 | 11 | 0 |
| K811188 | NORELCO BLOOD PRESSURE METER | North American Philips Corp. | 1981-05-15 | 16 | 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