Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Philips Park · Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

83 daysmedian FDA review time

335 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K854279	NORELCO ELECTRONIC DIGITAL BP METER HC3030	Philips Park	1986-11-17	389
K855048	NORELCO DIGITAL BLOOD PRESSURE METER HC3001	Philips Park	1986-11-17	335
K855177	NORELCO ELECTRNIC DIGITAL BLOOD PRESSURE METER	Philips Park	1986-11-07	316
K854023	NORELCO ELECTRONIC DIGITAL BP METER HC3501	Philips Park	1986-03-26	177
K854800	NORELCO DIGITAL THERMOMETER, MODEL HT 960	Philips Park	1986-01-09	38
K852128	NORELCO ELECTRONIC DIGITAL BP METER HC3501	Philips Park	1985-09-12	120
K852037	NORELCO ELECTRONIC DIGITAL BLOOD PRESSURE METER	Philips Park	1985-06-11	33
K851049	NORELCO BLOOD PRESSURE METER	Philips Park	1985-05-16	63
K851010	NORELCO DIGITAL MODEL 987 THERMOMETER	Philips Park	1985-04-04	23
K851075	NORELCO DIGITAL MODEL 970 THERMOMETER	Philips Park	1985-04-04	17
K833753	AC ADAPTERS FOR BLOOD PRESSURE METERS	Philips Park	1984-01-30	83

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