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

HIN — Predicate Candidate Screening

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

100 daysmedian FDA review time

317 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K142525	PK Lap Loop	Olympus Winter & Ibe GmbH	2014-11-21	74
K130305	LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SI	Lina Medical Aps	2013-07-24	169
K122983	KSEA BIPOLAR ELECTRODE	KARL STORZ Endoscopy-America, Inc.	2013-06-26	273
K122605	PKS BILL	Gyrus Acmi, Inc.	2012-12-05	100
K113080	TUBALGATOR	Mectra Labs, Inc.	2012-06-29	255
K111751	VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT I	ETHICON, Inc.	2011-12-02	163
K111059	GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)	Gyrus Acmi, Inc.	2011-09-01	136
K990147	BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.	Richard Wolf Medical Instruments Corp.	1999-04-16	87
K971565	BICOAG COAGULATING FORCEPS	Everest Medical Corp.	1998-03-12	317
K926517	ELMED LBC 50-P	Elmed, Inc.	1994-11-15	685
K943776	COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES	Richard Wolf Medical Instruments Corp.	1994-11-03	93
K911699	STI TISSUE MANIPULATOR	Surgical Technologies, Inc.	1991-06-13	58
K871745	MODEL 26021C BIPOLAR COAGULATOR	KARL STORZ Endoscopy-America, Inc.	1987-07-10	66
K790043	TRACOR, CANNULA, BICEPTS BIPOLAR	Neomed Corp.	1979-02-08	34
K781109	FORCEPS, ELECTROSURGICAL	Kli	1978-09-14	76
K781089	ONE INCISION BI-POLAR ELECTRO. FORCEPS	Kli	1978-07-17	18

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