Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LXV — Predicate Candidate Screening
22 FDA 510(k) clearances under this product code; the 50 most recent screened below.
123 daysmedian FDA review time
299 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220231 | GyroStim | Ultrathera Technologies, Inc. | 2022-04-27 | 90 | 0 |
| K200529 | Orion | Interacoustics A/S | 2020-08-12 | 163 | 0 |
| K192652 | TRV | Interacoustics A/S | 2020-05-27 | 246 | 0 |
| K183661 | ClearEdge Balance System | Quadrant Biosciences | 2019-10-22 | 299 | 0 |
| K190735 | EQ Balance | Upright Science, Inc. | 2019-08-16 | 148 | 0 |
| K173669 | K-D Balance | King-Devick Technologies, Inc. | 2018-04-02 | 123 | 0 |
| K121590 | VESTIBULAR ANALYSIS APPARATUS | Capacity Sports, LLC | 2012-09-20 | 112 | 0 |
| K102364 | NYDIAG 200 | Interacoustics A/S | 2010-12-23 | 125 | 0 |
| K082634 | VERTIGONE BPPV GOGGLE | Vertigone, Inc. | 2009-04-07 | 209 | 0 |
| K081602 | DIZZYFIX | Clearwater Clinical Limited | 2008-09-19 | 105 | 0 |
| K071973 | EPLEY OMNIAX | Vesticon | 2008-06-20 | 339 | 0 |
| K070676 | KOREBALANCE (KINESTHETIC ABILITY TRAINER) | Sportkat, LLC | 2007-04-18 | 37 | 0 |
| K070085 | BALANCE REHABILITATION UNIT (BRU) | Medicaa (Uruguay) S.A. | 2007-02-26 | 48 | 0 |
| K971549 | VMT SYSTEM | Target Health, Inc. | 1998-10-05 | 525 | 0 |
| K922037 | SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR | Micromedical Technologies, Inc. | 1992-10-26 | 178 | 0 |
| K911795 | KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000) | Breg, Inc. | 1991-11-19 | 211 | 0 |
| K891008 | VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ) | Micromedical Technologies, Inc. | 1989-05-31 | 89 | 0 |
| K884926 | BALANCE SYSTEM | Chattanooga Group, Inc. | 1989-02-27 | 91 | 0 |
| K872093 | RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING | Ics Medical Corp. | 1987-09-16 | 107 | 0 |
| K851744 | EQUITEST | Neurocom International, Inc. | 1985-08-05 | 98 | 0 |
| K781268 | CHAIR, VESTIBULAR, ROTARY, COMPUT. | Contraves | 1978-08-14 | 21 | 0 |
| K771618 | COMPUTERIZED POSTURE PLATFORM | Contraves Goerz Corp. | 1977-09-12 | 19 | 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