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

Parexel Intl. Corp. — Predicate Candidate Screening

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

88 daysmedian FDA review time

246 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K900385	ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE	Parexel Intl. Corp.	1991-07-09	526
K904901	L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC	Parexel Intl. Corp.	1991-03-26	147
K904902	SMA 26 TRANSDUCER	Parexel Intl. Corp.	1991-03-26	147
K884800	ACTA GENOS ELECTROCARDIOGRAPH	Parexel Intl. Corp.	1989-06-22	218
K862414	FUJI CR IMAGING PLATE	Parexel Intl. Corp.	1987-02-26	246
K864519	PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)	Parexel Intl. Corp.	1987-02-13	88
K862416	FTI 100 MEDICAL THERMAL IMAGER	Parexel Intl. Corp.	1986-07-01	6
K862415	TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM	Parexel Intl. Corp.	1986-07-01	6
K853295	EMODREN EXCHANGEABLE PLASTIC BELLOWS	Parexel Intl. Corp.	1985-08-20	14
K853296	EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN	Parexel Intl. Corp.	1985-08-15	9
K851322	PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH	Parexel Intl. Corp.	1985-05-16	44
K842123	PERSONAL CL SINGLE-CHANNEL ELECTROCAR	Parexel Intl. Corp.	1984-11-16	171
K842208	NATURA-TONE OR LUXOPAL CL ACRYLIC	Parexel Intl. Corp.	1984-07-31	57
K841826	NATURA-DENT VACUUM-FIRED PORCELAIN TEETH	Parexel Intl. Corp.	1984-07-12	71

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