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

JMF — Predicate Candidate Screening

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

35 daysmedian FDA review time

55 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K944933	IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN)	Diagnostic Products Corp.	1995-03-10	155
K840588	AMERLEX HUMAN PLACENTAL LACTOGEN	Amersham Corp.	1984-04-04	55
K823292	IMMOPHASE TM HPL RADIOIMMUNOASSAY	Corning Medical & Scientific	1982-12-28	53
K823201	HUMAN PLACENTAL LACTOGEN KIT	Diagnostic Products Corp.	1982-11-29	34
K811370	NATAL-TEC HPL	Armkel, LLC	1981-05-29	15
K802454	GESTE FOLLOW KIT DETERM. OF HPL	Syn-Kit, Inc.	1980-11-12	35
K791854	CENTRIA HPL RIA	Union Carbide Corp.	1979-10-01	12
K790919	HPL RIA KIT	Technia Diagnostics , Ltd.	1979-06-28	45
K782099	RIA TEST, NORDICALB HPL	Nordiclab Intl.	1979-01-10	23
K771656	PROLACTIN RIA DIAG. KIT	Abbott Laboratories	1977-09-22	24
K770659	RIALYZE HPL (RIA)	Miles Laboratories, Inc.	1977-05-20	43

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