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

Core Dynamics, Inc. — Predicate Candidate Screening

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

92 daysmedian FDA review time

298 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days
K992250	CORE AUDIBLE TROCAR II	Core Dynamics, Inc.	1999-09-24	80
K992190	CORE POUCH	Core Dynamics, Inc.	1999-09-01	64
K955490	LAPAROSCOPIC KNITTER	Core Dynamics, Inc.	1996-01-22	80
K953903	LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM	Core Dynamics, Inc.	1995-10-20	92
K953409	LAPAROSCOPIC TROCAR	Core Dynamics, Inc.	1995-10-16	88
K950457	CANNUAL AND TROCAR, SUPERPUBIC	Core Dynamics, Inc.	1995-05-05	91
K943172	CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR	Core Dynamics, Inc.	1994-07-28	38
K935826	LAPAROSCOPIC/SUCTION/IRRIGATION PROBE	Core Dynamics, Inc.	1994-05-18	163
K932118	ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET	Core Dynamics, Inc.	1994-03-17	318
K932021	ENTREE CANNULA FASCIA ANCHORS	Core Dynamics, Inc.	1994-01-11	263
K932020	ENTREE BLUNT TIP TROCAR AND ADAPTER	Core Dynamics, Inc.	1994-01-11	263
K926477	BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO	Core Dynamics, Inc.	1993-11-12	318
K933909	SCOPE WASH	Core Dynamics, Inc.	1993-10-15	65
K931138	CORE DYNAMICS LAPAROSCIPIC IRRIGATION PUMP	Core Dynamics, Inc.	1993-09-07	186
K932022	ENTREE THORACOSCOPY CANNULA SET	Core Dynamics, Inc.	1993-07-28	96
K930512	SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES	Core Dynamics, Inc.	1993-07-23	172
K924410	LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTATION	Core Dynamics, Inc.	1993-06-25	298
K922655	SUCTION/IRRIGATION Y TUBING SET	Core Dynamics, Inc.	1992-07-14	41
K914426	ENTREE NEEDLE	Core Dynamics, Inc.	1991-11-27	56
K911813	ENTREE CANNULA	Core Dynamics, Inc.	1991-07-19	87
K910246	CORE DISPOSABLE SUCTION/IRRIGATION TUBING	Core Dynamics, Inc.	1991-04-29	97
K901413	CORE DISPOSABLE INSUFFLATION TUBING	Core Dynamics, Inc.	1990-09-24	182
K901407	CORE DISPOSABLE TROCARS	Core Dynamics, Inc.	1990-06-08	74

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