Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GZT — Predicate Candidate Screening
43 FDA 510(k) clearances under this product code; the 50 most recent screened below.
55 daysmedian FDA review time
313 days90th percentile
43clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210615 | Thompson Brain Retractor Table Mounted (TM), Thompson Brain | Thompson Surgical Instruments, Inc. | 2022-05-13 | 438 | 0 |
| K202694 | Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS | Vycor Medical, Inc. | 2021-01-14 | 120 | 0 |
| K202072 | MindsEye Expandable Port | Minnetronix Neuro, Inc. | 2020-08-26 | 30 | 0 |
| K180610 | Geister retractor for neuro - and spine surgery | Geister Medizin Technik GmbH | 2018-08-29 | 174 | 0 |
| K172433 | NICO BrainPath | Nico Corporation | 2017-09-07 | 27 | 0 |
| K161680 | MEDICON Spinal Spreading Systems | Medicon EG | 2017-03-24 | 280 | 0 |
| K161318 | Phantom Fukushima Neurological Holding Systems, Phantom Mast | Tedan Surgical Innovations, LLC | 2017-03-20 | 313 | 0 |
| K161004 | Self-retaining Retractor | Fetzer Medical GmbH & Co. KG | 2016-09-09 | 151 | 0 |
| K150378 | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd' | Nico Corporation | 2015-06-12 | 119 | 0 |
| K120691 | BRAIN PORT | Nico Corporation | 2012-06-05 | 90 | 2 |
| K113273 | SPOTLIGHT ACCESS SYSTEM | Johnson & Johnson | 2012-01-27 | 81 | 0 |
| K112913 | SPOTLIGHT ACCESS SYSTEM | Johnson & Johnson | 2011-12-16 | 74 | 0 |
| K093054 | SCALP DURA RETRACTOR, MODEL KS00474 | KARL STORZ Endoscopy-America, Inc. | 2010-11-15 | 411 | 0 |
| K090272 | SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES) | Cardinal Health, Inc. | 2009-03-18 | 42 | 0 |
| K071771 | INSTRUMED RETRACTORS | Instrumed International, Inc. | 2007-08-02 | 34 | 0 |
| K071338 | FLEX ARM RETRACTOR SYSTEM | Koros USA, Inc. | 2007-05-29 | 15 | 0 |
| K062814 | PIPELINE II ACCESS SYSTEM | Depuy Spine, Inc. | 2006-12-15 | 86 | 0 |
| K060973 | VYCOR SURGICAL ACCESS SYSTEMS | Vycor Medical, LLC | 2006-07-26 | 107 | 1 |
| K060097 | GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 0 | KLS-Martin L.P. | 2006-02-27 | 45 | 0 |
| K050706 | HARMONY PORT SYSTEM, MODEL 1907 SERIES | Spinal Concepts, Inc. | 2005-04-15 | 28 | 1 |
| K992898 | THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM | Bright Medical Instruments | 1999-10-21 | 55 | 0 |
| K964402 | VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM | V. Mueller Neuro/Spine | 1997-01-23 | 80 | 0 |
| K960807 | TEW CRANIAL/SPINAL RETRACTOR MODEL A1090 | Ohio Medical Instrument Co., Inc. | 1996-05-17 | 79 | 0 |
| K945040 | HAMID HOOK ATTACHMENT DEVICE FOR HEMILAMINECTOMY RETRACTOR | Hamid M. Mehdizadeh, M.D. | 1995-01-13 | 91 | 0 |
| K935529 | CERVICAL SELF-RETAINING RETRACTOR | T. Korossurgical Instruments Corp. | 1994-03-22 | 126 | 0 |
| K924876 | TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED | Graham-Field, Inc. | 1994-03-01 | 524 | 0 |
| K913233 | CODMAN LHALO SPLIT RING RETRACTOR SYSTEM | Codman & Shurtleff, Inc. | 1991-07-31 | 9 | 0 |
| K910621 | BLADES FOR SPINAL LAMINECTOMY RETRACTOR | International Hospital Supply Co. | 1991-04-01 | 48 | 0 |
| K905445 | ADSON-BECKMAN RETRACTOR, SPINAL | A. Henniss | 1991-01-25 | 52 | 0 |
| K902517 | NEUROSURGICAL HEADFRAME ACCESSORIES | Sims Surgical, Inc. | 1990-07-03 | 26 | 0 |
| K885120 | ESI MODEL MS-103 | Electrical Systems Div. | 1990-01-19 | 403 | 0 |
| K896156 | COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM | Stereotactic Medical Systems, Inc. | 1989-12-06 | 43 | 0 |
| K895395 | V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR | Baxter Healthcare Corp | 1989-10-19 | 48 | 0 |
| K895537 | MODIFIED MEMORY RETRACTOR ARM | Medical Equipment Development Co., Inc. | 1989-09-22 | 10 | 0 |
| K892543 | NEUROSURICAL RETRACTORS - VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | 1989-05-05 | 24 | 0 |
| K882071 | CRANK FRAME RETRACTOR | Karlin Technology, Inc. | 1988-06-10 | 24 | 0 |
| K881160 | CRANK FRAME RETRACTOR | T. Korossurgical Instruments Corp. | 1988-04-06 | 19 | 0 |
| K874829 | MEDCO MEMORY RETRACTOR SYSTEM | Medical Equipment Development Co., Inc. | 1988-03-24 | 121 | 0 |
| K874956 | SELF-RETAINING RETRACTOR FOR NEUROSURGERY | Solway, Inc. | 1988-01-28 | 57 | 0 |
| K873691 | CEDAR(TM) RETRACTOR RING | Cedar Surgical, Inc. | 1987-09-28 | 20 | 0 |
| K830332 | BUDDE-HALO RETRACTOR | Ohio Medical Instrument Co., Inc. | 1983-03-02 | 29 | 1 |
| K801855 | CYCLOPAC TENS | Dow Corning Wright | 1980-08-13 | 9 | 0 |
| K801151 | DISPOSABLE SKIN RETRACTOR | Cimarron Instruments, Inc. | 1980-05-20 | 7 | 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