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

HES — Predicate Candidate Screening

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

74 daysmedian FDA review time

182 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K140761	KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN	Carefusion 2200, Inc.	2014-04-21	26
K000340	HYSTALOG HSG CATHETER	Rocket Medical Plc	2000-04-19	76
K903209	MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER	Adler Instrument Co.	1990-12-21	154
K903208	MAXI-FLOW INSUFFLATOR TUBING SET	Adler Instrument Co.	1990-12-17	150
K904473	KRONNER MANIPUJECTOR	Unimar, Inc.	1990-12-14	74
K901413	CORE DISPOSABLE INSUFFLATION TUBING	Core Dynamics, Inc.	1990-09-24	182
K891290	SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER	Cook Ob/Gyn	1989-05-23	74
K890869	BARD HYSTEROSALPINGOGRAPHY CATHETERS	C.R. Bard, Inc.	1989-04-25	63
K875137	LAPAROFLATOR 3000, STANDARD AND ELECTRONIC	F.M. Wiest USA, Inc.	1988-03-02	78
K873515	UTERINE INJECTOR 2MM	Zinnanti Surgical Instruments, Inc.	1987-09-29	29
K862310	CABOT MEDICAL VARIABLE FLOW INSUFFLATOR	Cabot Medical Corp.	1986-08-12	56
K844173	FEMTEST	Bionexus, Inc.	1985-08-14	293
K841682	UTERINE INJECTOR 4.0MM	Humi Corp.	1984-07-03	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