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

Kendall Research Center — Predicate Candidate Screening

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

28 daysmedian FDA review time

82 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K802225	TENDER-SORB DRAIN SPONGES	Kendall Research Center	1980-09-26	14	0
K781357	T.E.D. SEQUENTIAL COMPRESSION SLEEVES	Kendall Research Center	1978-09-20	43	0
K780408	MICRONET LIGHT DRESSING SPONGE	Kendall Research Center	1978-03-22	9	0
K780062	CATHETER/HEMOSTATIC/GERIATRIC	Kendall Research Center	1978-02-14	33	1
K780120	ANESTHESIA TRAY, CAUDAL	Kendall Research Center	1978-02-06	14	0
K772133	URINE SPECIMEN COLLECTING DEVICE	Kendall Research Center	1977-11-28	14	0
K772134	SYRINGE, IRRIGATION, PRE-FILLED	Kendall Research Center	1977-11-28	14	0
K771655	CURITY PEAKOMETER	Kendall Research Center	1977-10-14	46	0
K771079	CURITY IRRIGATION TRAY	Kendall Research Center	1977-09-15	92	0
K771452	CONFORM STRETCH BANDAGE (5SIZES)	Kendall Research Center	1977-09-12	40	0
K771563	CONFORM ELASTIC NETTING	Kendall Research Center	1977-09-12	28	0
K770924	GREEN RADIOPAQUE IN SURG. SPONGES	Kendall Research Center	1977-08-10	82	0
K760343	TRAY, CURITY CONTINUOUS EPIDURAL	Kendall Research Center	1976-08-11	12	0
K760094	SPONGE, CURITY WASHED GAUZE	Kendall Research Center	1976-07-16	25	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