510(k) Report

510(k) · Cleared

Cleared

The Slide

K203712510(k) TraditionalCleared Jul 20, 2021211-day reviewClass II21 CFR 872.5570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biotex, Inc. · LQZ Device, Jaw Repositioning

Cleared on Jul 20, 2021 as substantially equivalent to K121340 (Somnomed, Inc., 2012) after a 211-day review. Its family tree reaches back 6 generations to 1989.

Decided
Jul 20, 2021
Review
211 days
Class
Class II
Product code
LQZ
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K882303 (1989). 7 ancestors in all. No later device cites it as a predicate yet.

  1. Root · 6 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
  2. 5 generations backK962516 Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 1996
  3. 4 generations backK042161 Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd. · 2004
  4. 3 generations backK050592 Somnomed Mas RxaSomnomed, Ltd. · 2005
  5. 2 generations backK073004 Somnomed BflexSomnomed, Inc. · 2008
  6. 1 generation backK121340 Somnodent G2Somnomed, Inc. · 2012
  7. This deviceK203712 The SlideBiotex, Inc. · 2021
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K882303H&M Anti-Snoring DeviceHays & Meade, Inc.1989—
−5K962516Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc.1996—
−4K042161Anti-Snoring/Sleep Apnea DeviceRj & VK Bird Pty, Ltd.2004—
−3K050592Somnomed Mas RxaSomnomed, Ltd.2005—
−2K073004Somnomed BflexSomnomed, Inc.2008—
−1K121340Somnodent G2Somnomed, Inc.2012—
0 (this device)K203712The SlideBiotex, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
FIG. 1 — Lineage of K203712, 1989–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LQZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LQZ device

  1. #1 K233754 AIO Breathescore 12.9 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K121340Somnodent G2
Summary page 4
…K203712 3. PREDICATE DEVICE Predicate Manufacturer: Somnomed Predicate Trade Name: Somnodent G2 Predicate 510(k): K121340 No reference devices were used in this submission. 4. DEVICE DESCRIPTION 4.1. The SlideTM is a prescribed intraoral devi…
Somnomed, Inc.2012—

Also cleared against K121340: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 7.4 years on median.
  • None of the 7 ancestors has a recall.
  • 2 other devices also cite its predicate K121340.

How does its category compare?

All LQZ devices

LQZ Device, Jaw Repositioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · LQZ

1in 2024

2009: 22011: 12012: 22013: 12017: 12020: 22021: 12023: 12024: 1
2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LQZ

Too few LQZ 510(k)s in any year since 2007 to give a median.

Recalls per year · LQZ

No recall names LQZ since 2007.

Adverse event reports per year · LQZ

2in 2021

2009: 12010: 12012: 22014: 22016: 42017: 12021: 2
2007high 4 (2016) · low 0 (2007)2025

MAUDE reports naming product code LQZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20092—01
20100—01
20111—00
20122—02
20131—00
20140—02
20150—00
20160—04
20171—01
20180—00
20190—00
20202—00
20211—02
20220—00
20231—00
20241—00
20250—00
20260—0—

What is it indicated for?

The Slide is for use to reduce night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K203712: The Slide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203712

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026