Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LQZ — Predicate Candidate Screening
27 FDA 510(k) clearances under this product code; the 50 most recent screened below.
135 daysmedian FDA review time
574 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233754 | AIO Breathe | Aiomega, LLC | 2024-02-23 | 93 | 0 |
| K230532 | RADx Intraoral Appliance for Snoring and Sleep Apnea | Achaemenid, LLC | 2023-07-12 | 135 | 0 |
| K203712 | The Slide | Biotex, Inc. | 2021-07-20 | 211 | 0 |
| K191320 | Slow Wave DS8 | Slow Wave, Inc. | 2020-10-02 | 506 | 0 |
| K192581 | The NightBlocks Appliance | Advanced Facialdontics, LLC | 2020-01-28 | 131 | 0 |
| K162816 | SML-OSA2 Appliances | Selane Products, Inc. | 2017-07-27 | 294 | 0 |
| K130130 | ATG/SM-OSA APPLIANCES | Selane Products, Inc. | 2013-08-26 | 221 | 0 |
| K112627 | MILLENIUM ANTI-SNORING DEVICE | Millenium Dental Laboratory, Inc. | 2012-06-06 | 271 | 0 |
| K112766 | SNORKEL | Fellmar Company | 2012-06-04 | 256 | 0 |
| K113201 | NARVAL CC | Resmed Sas | 2011-12-01 | 31 | 0 |
| K090911 | IST SNORING APPLIANCE | Dental Crafters | 2009-09-11 | 163 | 0 |
| K091035 | FULL BREATH SLEEP APPLIANCE LOWER (FBSL) | Bryan Keropian Dds | 2009-06-24 | 75 | 0 |
| K061228 | FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR | Bryan Keropian Dds | 2006-05-26 | 24 | 0 |
| K053065 | FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (PO | Bryan Keropian Dds | 2006-01-03 | 63 | 0 |
| K052862 | FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) | Bryan Keropian Dds | 2005-12-30 | 80 | 0 |
| K032410 | SNORENTI | James P Boyd | 2005-02-28 | 574 | 0 |
| K971818 | SNOREX | Snorex (Nz) , Ltd. | 1997-12-18 | 216 | 0 |
| K960673 | OSAP | Snorefree, Inc. | 1996-05-09 | 79 | 0 |
| K955503 | ADJUSTABLE PM POSITIONER | Jonathan A. Parker, D.D.S. | 1996-02-08 | 69 | 0 |
| K953293 | PM POSITIONER | Jonathan A. Parker, D.D.S. | 1995-09-15 | 63 | 0 |
| K945820 | DESRA | D.S.R.A., Inc. | 1995-06-15 | 199 | 0 |
| K946112 | ELASTOMERIC SLEEP APPLIANCE | Village Park Orthodontics | 1995-06-14 | 181 | 0 |
| K932932 | SNOREMASTER SNORE REMEDY | The Snoremaster Co. | 1995-02-10 | 604 | 0 |
| K922818 | SNORE-NO-MORE | Great Lakes Orthodontics, Ltd. | 1994-02-09 | 608 | 0 |
| K902790 | NAPA | G-Ortho Lab | 1990-09-19 | 85 | 0 |
| K880956 | SNOAR(TM) OPEN AIRWAY APPLIANCE | Kent J. Toone, D.D.S. | 1988-05-11 | 65 | 0 |
| K870501 | THE EQUALIZER AIRWAY DEVICE | Sleep Renewal, Inc. | 1987-03-04 | 28 | 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