Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ETB — Predicate Candidate Screening
74 FDA 510(k) clearances under this product code; the 50 most recent screened below.
41 daysmedian FDA review time
158 days90th percentile
74clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260718 | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Pro | MED-EL Elektromedizinische Geräte GmbH | 2026-04-03 | 29 | 0 |
| K260720 | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stape | MED-EL Elektromedizinische Geräte GmbH | 2026-04-03 | 29 | 0 |
| K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXAC | MED-EL Elektromedizinische Geräte GmbH | 2025-01-17 | 266 | 0 |
| K241142 | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stape | MED-EL Elektromedizinische Geräte GmbH | 2025-01-17 | 267 | 0 |
| K130512 | NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTO | Heinz Kurz GmbH Medizintechnik | 2013-12-02 | 278 | 0 |
| K112616 | NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS | Heinz Kurz GmbH Medizintechnik | 2013-02-08 | 519 | 0 |
| K080070 | K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTH | Grace Medical, Inc. | 2008-04-17 | 98 | 0 |
| K063374 | NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PIST | Grace Medical, Inc. | 2006-12-06 | 28 | 0 |
| K061853 | GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OS | Grace Medical, Inc. | 2006-08-18 | 49 | 0 |
| K060518 | PARTIAL OSSICULAR REPLACEMENT PROSTHESES | Grace Medical, Inc. | 2006-06-28 | 121 | 1 |
| K033554 | SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS | Gyrus Ent LLC | 2003-11-24 | 12 | 0 |
| K021479 | CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 | Heinz Kurz GmbH Medizintechnik | 2002-05-21 | 13 | 0 |
| K013573 | CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 | Heinz Kurz GmbH Medizintechnik | 2001-11-09 | 11 | 0 |
| K010442 | KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 10 | Heinz Kurz | 2001-03-08 | 22 | 0 |
| K003214 | SMITH & NEPHEW PISTONS | Gyrus Ent LLC | 2000-10-31 | 18 | 0 |
| K002737 | SMITH & NEPHEW PORPS & TORPS | Gyrus Ent LLC | 2000-10-12 | 41 | 0 |
| K002897 | TITANIUM MIDDLE EAR PROSTHESES | Xomed, Inc. | 2000-10-11 | 23 | 1 |
| K002464 | SMITH & NEPHEW OFF-CENTERED PORP | Gyrus Ent LLC | 2000-08-29 | 19 | 0 |
| K002221 | KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103 | Heinz Kurz GmbH Medizintechnik | 2000-08-09 | 16 | 0 |
| K001142 | AUDIO TECHNOLOGIES S:R.1 | Audio Technologies S.R.L. | 2000-06-23 | 74 | 0 |
| K000858 | WEHRS INCUS-STAPES | Gyrus Ent LLC | 2000-04-03 | 18 | 0 |
| K000256 | CAP PORP, CAP TORP | Gyrus Ent LLC | 2000-02-11 | 14 | 0 |
| K993234 | MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS | Micromedics, Inc. | 1999-11-10 | 44 | 0 |
| K992839 | SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE | Heinz Kurz GmbH Medizintechnik | 1999-09-16 | 24 | 0 |
| K991394 | STAPES PROSTHESES | Grace Medical, Inc. | 1999-05-18 | 27 | 0 |
| K990923 | TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 | Heinz Kurz | 1999-03-31 | 12 | 0 |
| K981045 | EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS | Exmoor Plastics , Ltd. | 1998-05-20 | 61 | 0 |
| K974365 | MILLS INCUS HA SLEEVE | Exmoor Plastics , Ltd. | 1998-01-22 | 64 | 0 |
| K973356 | K-PISTON WITH BAND HOOK /ANGULAR PISTON | Heinz Kurz | 1997-11-21 | 74 | 0 |
| K972815 | PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT | Grace Medical, Inc. | 1997-10-08 | 72 | 0 |
| K972734 | PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) | Mednet Locator, Inc. | 1997-09-05 | 45 | 0 |
| K972737 | CAUSSE PISTON | Mednet Locator, Inc. | 1997-09-05 | 45 | 0 |
| K972492 | BELL PROSTHESIS (PARTIAL) | Heinz Kurz | 1997-08-04 | 33 | 0 |
| K964909 | ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS | Xomed, Inc. | 1997-03-10 | 91 | 0 |
| K962564 | RICHARDS TOTAL/PARTIAL PROSTHESIS | Gyrus Ent LLC | 1997-01-22 | 205 | 0 |
| K964798 | PARTIAL OSSICULAR REPLACEMENT PROSTHESIS | Anthony D. Prescott | 1997-01-02 | 34 | 0 |
| K963752 | PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS | Grace Medical, Inc. | 1996-10-10 | 22 | 0 |
| K945105 | POLY/PLATINUM WIRE PISTON | Micromed Development Corp. | 1996-05-14 | 574 | 0 |
| K955613 | MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS | Misten Medical Corp. | 1995-12-22 | 11 | 0 |
| K954517 | TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDI | Trebay Medical Corp. | 1995-10-27 | 29 | 0 |
| K952481 | RICHARDS PORP | Smith & Nephew Richards, Inc. | 1995-06-16 | 17 | 0 |
| K950886 | HAPEX PORP | Smith & Nephew Richards, Inc. | 1995-03-15 | 15 | 0 |
| K950885 | HAPEX MALLEABLE PORP | Smith & Nephew Richards, Inc. | 1995-03-15 | 15 | 0 |
| K950984 | HAPES MALLEABLE INCUS STAPES | Smith & Nephew Richards, Inc. | 1995-03-15 | 12 | 0 |
| K950887 | HAPEX INCUS | Smith & Nephew Richards, Inc. | 1995-03-15 | 15 | 0 |
| K945104 | MICROMED PARTIAL REGULAR AND PARTIAL OFFSET | Micromed Development Corp. | 1994-11-22 | 35 | 0 |
| K945107 | POLY-WIRE PISTON | Micromed Development Corp. | 1994-11-22 | 35 | 0 |
| K945108 | POLY PISTON | Micromed Development Corp. | 1994-11-22 | 35 | 0 |
| K925443 | INCUDOSTAPEDIAL JOINT | Smith & Nephew Richards, Inc. | 1993-03-08 | 131 | 0 |
| K915120 | TEF/PLATINUM PISTON | River Medical, Inc. | 1991-12-27 | 44 | 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