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

Clinipad Corp. — Predicate Candidate Screening

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

96 daysmedian FDA review time

335 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K931560	CARDIAC CATHETERIZATION TRAY	Clinipad Corp.	1994-07-11	468
K931668	PICC INSERTION TRAY	Clinipad Corp.	1994-03-07	335
K932071	I.V. START KIT	Clinipad Corp.	1994-02-17	295
K932010	V.A.D. ACCESS KIT	Clinipad Corp.	1994-02-03	286
K932036	LACERATION TRAY	Clinipad Corp.	1993-12-13	230
K932016	TRACHEOSTOMY CARE TRAY	Clinipad Corp.	1993-11-03	194
K862562	PUNCH BIOPSY KIT	Clinipad Corp.	1986-10-07	96
K862563	TRACHEOSTOMY CLEANSING SOLUTION	Clinipad Corp.	1986-07-15	12
K833075	WET DRESSING KIT	Clinipad Corp.	1984-01-27	140
K833432	CATHETER INSERTION KIT	Clinipad Corp.	1983-12-28	84
K830476	OR PREP KIT	Clinipad Corp.	1983-03-31	44
K820171	SUBCLAVIAN INSERTION KIT	Clinipad Corp.	1982-03-02	40
K812130	SPIKE GUARD	Clinipad Corp.	1981-09-09	44
K811247	CATHETER MAINTENANCE KIT	Clinipad Corp.	1981-06-12	38
K810240	CLINIGUARD STERILE	Clinipad Corp.	1981-02-19	22
K800527	CLINIGUARD	Clinipad Corp.	1980-05-08	62

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