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

Erbe USA, Inc. — Predicate Candidate Screening

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

58 daysmedian FDA review time

261 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K221177	Erbe's Tubing/Cap Sets	Erbe USA, Inc.	2022-08-11	108	1
K191438	ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector	Erbe USA, Inc.	2019-06-27	28	0
K190469	ERBEFLO 2 Disposable Tubing System	Erbe USA, Inc.	2019-05-23	86	1
K182444	ERBEFLO Olympus Scope Port Connector	Erbe USA, Inc.	2018-11-06	60	0
K162152	Erbe’s CO2 Tubing/Cap Sets	Erbe USA, Inc.	2016-08-31	29	1
K143306	ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe	Erbe USA, Inc.	2015-10-27	343	0
K151041	ERBECRYO 2 Cryosurgical Unit with accessories	Erbe USA, Inc.	2015-05-04	14	0
K143186	Endo Quickconnect Olympus Scope Port Connector, Endo Quickco	Erbe USA, Inc.	2014-12-18	43	0
K132340	ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, E	Erbe USA, Inc.	2013-12-17	144	1
K133180	ERBE ESU MODEL VIO DV WITH ACCESSORIES	Erbe USA, Inc.	2013-12-11	55	0
K103696	ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS	Erbe USA, Inc.	2011-03-22	95	0
K103235	ERBEFLO 2 DISPOSABLE TUBING SYSTEM	Erbe USA, Inc.	2010-12-23	51	0
K101108	ERBE ESU MODEL VIO 100 C WITH ACCESSORIES	Erbe USA, Inc.	2010-07-16	87	0
K083608	ERBE HYBRID KNIFE	Erbe USA, Inc.	2009-08-26	264	0
K083452	ERBE MODEL VIO 300 D WITH ACCESSORIES	Erbe USA, Inc.	2008-12-31	40	0
K080715	ERBE VIO ESU, MODEL VIO 200 S	Erbe USA, Inc.	2008-04-02	20	0
K072404	ERBE ERBEJET 2 SYSTEM	Erbe USA, Inc.	2007-10-31	65	0
K062712	ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 201	Erbe USA, Inc.	2007-01-26	137	0
K060484	ERBE VIO ESU, MODEL VIO 300 D	Erbe USA, Inc.	2006-03-16	20	0
K060183	ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILTE	Erbe USA, Inc.	2006-02-16	23	0
K060170	ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS	Erbe USA, Inc.	2006-02-16	24	0
K051509	ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES	Erbe USA, Inc.	2005-07-27	50	0
K033421	ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS	Erbe USA, Inc.	2004-10-14	353	0
K033590	ERBE HELIX HYDRO-JET	Erbe USA, Inc.	2004-01-30	81	0
K024047	ERBE VIO APC WITH ACCESSORIES	Erbe USA, Inc.	2003-01-08	30	0
K023886	ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 D	Erbe USA, Inc.	2002-12-12	21	0
K023812	NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N	Erbe USA, Inc.	2002-11-29	14	0
K022613	HELIX HYDRO-JET	Erbe USA, Inc.	2002-10-25	80	0
K013348	MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS	Erbe USA, Inc.	2001-10-26	17	0
K003462	ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,2	Erbe USA, Inc.	2001-01-04	58	0
K992769	ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109	Erbe USA, Inc.	1999-10-14	58	0
K992764	ERBE APC RASPATORY HANDLE AND TIP, MODEL 20132-102, 20132-10	Erbe USA, Inc.	1999-10-14	58	0
K972269	DISPOSABLE PATIENT RETURN ELECTRODE	Erbe USA, Inc.	1997-07-09	22	0
K963189	ERBE APC 300 ARGON PLASMA COAGULATOR AND ACCESSORIES - ARGON	Erbe USA, Inc.	1996-11-26	104	0
K960569	DISPOSABLE PATIENT RETURN ELECTRODE	Erbe USA, Inc.	1996-03-11	34	0
K953159	ERBOTOM ICC BIPOLAR	Erbe USA, Inc.	1995-10-04	118	0
K935815	ERBOTOM ICC 50	Erbe USA, Inc.	1994-03-31	119	0
K933002	ERBOTOM ICC 350	Erbe USA, Inc.	1994-03-09	261	0
K933157	ERBOTOM ICC 200	Erbe USA, Inc.	1994-02-23	239	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