Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GZO — Predicate Candidate Screening
26 FDA 510(k) clearances under this product code; the 50 most recent screened below.
112 daysmedian FDA review time
260 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150804 | QBioScan | Medeia, Inc. | 2015-10-19 | 207 | 0 |
| K152216 | SudoC | Ld Technology, LLC | 2015-09-24 | 48 | 0 |
| K141872 | SUDOSCAN | Impeto Medical, Inc. | 2014-11-21 | 133 | 0 |
| K131568 | SUDO PATH | Ld Technology, LLC | 2013-06-28 | 29 | 0 |
| K111308 | ZYTO HAND CRADLE | Zyto Technologies, Inc. | 2011-08-30 | 112 | 0 |
| K102166 | ELECTRO INTERSTITIAL SCAN | Ld Technology, LLC | 2010-12-10 | 130 | 0 |
| K100233 | SUDOSCAN | Impeto Medical | 2010-06-14 | 139 | 0 |
| K053004 | MSAS-VANTAGE | Biomeridian, Int. | 2006-01-13 | 79 | 0 |
| K032935 | EPI-SCAN, MODEL P 100 | Edx Epi-Scan, Inc. | 2003-11-20 | 59 | 0 |
| K023355 | ASYRA | Galloway Technologies, LLC | 2003-06-24 | 260 | 0 |
| K020360 | ABR-2000 | Meridian Co., Ltd. | 2002-08-29 | 206 | 0 |
| K020567 | AKUPORT M1 | Vibrant Health | 2002-05-02 | 71 | 0 |
| K020564 | EAV KINDLING 2000S GSR DEVICE | Virbrant Health | 2002-04-30 | 69 | 0 |
| K020568 | AKUPORT M-2 | Vibrant Health | 2002-04-30 | 69 | 0 |
| K020565 | EAV COMBI-2 | Vibrant Health | 2002-04-30 | 69 | 0 |
| K010897 | MERIDIAN-PORTABLE | Meridian Co., Ltd. | 2001-06-19 | 85 | 0 |
| K003480 | BIOFIND | Bio-Scan, Inc. | 2001-05-11 | 183 | 0 |
| K001347 | MERIDIAN-II AND MERDIAN-PLUS | Meridian Co., Ltd. | 2000-11-03 | 189 | 0 |
| K993824 | MSAS PROFESSIONAL | Biomeridian, Int. | 2000-01-20 | 69 | 0 |
| K993202 | EIM-107 PREP-CHECK | General Devices | 1999-12-17 | 84 | 0 |
| K992129 | PHAZX VLD-100 | Phazx Systems, Inc. | 1999-09-17 | 86 | 0 |
| K970436 | E-READER | Natural Herbal Products, Inc. | 1997-08-15 | 191 | 0 |
| K943101 | GALVANIC SKIN RESPONSE DEVICE | Global Ent. | 1995-10-18 | 476 | 0 |
| K883112 | DERMATRON SKIN RESISTANCE METER | Raymar Electronics | 1989-08-10 | 381 | 0 |
| K874850 | EPI-SCAN SELECTIVE TISSUE CONDUCTANCE METER | Epi-Scan Corp. | 1988-05-20 | 169 | 0 |
| K842108 | UNIVERSAL EXAMINATION TABLE | Engineering Dynamics Corp. | 1984-07-17 | 49 | 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