Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Heinz Kurz GmbH Medizintechnik · Predicate Candidate Screening

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

25 daysmedian FDA review time

278 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K130512	NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTO	Heinz Kurz GmbH Medizintechnik	2013-12-02	278
K112616	NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS	Heinz Kurz GmbH Medizintechnik	2013-02-08	519
K071150	TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODE	Heinz Kurz GmbH Medizintechnik	2007-12-12	231
K042503	KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63	Heinz Kurz GmbH Medizintechnik	2004-10-01	16
K033796	KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS	Heinz Kurz GmbH Medizintechnik	2004-01-30	56
K021479	CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861	Heinz Kurz GmbH Medizintechnik	2002-05-21	13
K013573	CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257	Heinz Kurz GmbH Medizintechnik	2001-11-09	11
K011115	KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4	Heinz Kurz GmbH Medizintechnik	2001-05-02	20
K002221	KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103	Heinz Kurz GmbH Medizintechnik	2000-08-09	16
K001123	KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111	Heinz Kurz GmbH Medizintechnik	2000-04-21	14
K000127	KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 400	Heinz Kurz GmbH Medizintechnik	2000-04-12	85
K992839	SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE	Heinz Kurz GmbH Medizintechnik	1999-09-16	24
K973226	TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUB	Heinz Kurz GmbH Medizintechnik	1997-11-04	69
K972585	AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRES	Heinz Kurz GmbH Medizintechnik	1997-08-04	25

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