510(k) Report

510(k) · Cleared

Cleared

Adjustable Soft Palate Lifter

K895189510(k) TraditionalCleared Feb 9, 1990182-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

Ortho Publications, Inc. · LRK Device, Anti-Snoring

Cleared on Feb 9, 1990 after a 182-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Feb 9, 1990
Review
182 days
Class
Class II
Product code
LRK
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2022: 1 descendant cleared1990200020102020
  1. This deviceK895189 Adjustable Soft Palate LifterOrtho Publications, Inc. · 1990
  2. Descendant · cites it directly · 0 of its ownK222127 Soft Palate ElevatorThe Tmj Clinic PC · 2022

Most influential descendants

Showing 1 of 1 · See all
  • K222127Soft Palate ElevatorThe Tmj Clinic PC · 2022 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K895189Adjustable Soft Palate LifterOrtho Publications, Inc.1990—
+1K222127Soft Palate ElevatorThe Tmj Clinic PC2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
FIG. 1 — Lineage of K895189, 1990–2022Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LRK? 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 LRK device

  1. #1 K252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for…score 16.3 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K222127Soft Palate ElevatorThe Tmj Clinic PC20220

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?

  • Of its descendants, K222127 (The Tmj Clinic PC, 2022) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LRK devices

LRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LRK

14in 2025

2007: 12008: 32009: 32010: 82011: 102012: 102013: 92014: 112015: 62016: 102017: 72018: 102019: 132020: 52021: 102022: 112023: 52024: 62025: 142026 (partial year): 10
2007high 14 (2025) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LRK

107in 2025

2008: 109 days median2009: 88 days median2010: 195 days median2011: 134 days median2012: 142 days median2013: 233 days median2014: 219 days median2015: 117 days median2016: 157 days median2017: 170 days median2018: 200 days median2019: 150 days median2020: 80 days median2021: 126 days median2022: 154 days median2023: 156 days median2024: 254 days median2025: 107 days median2026 (partial year): 63 days median
2007high 254 (2024) · low 80 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LRK

1in 2025

2009: 22025: 12026 (partial year): 1
2007high 2 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LRK

653in 2025

2008: 12009: 112010: 72011: 692012: 4452013: 722014: 492015: 282016: 182017: 322018: 612019: 562020: 242021: 492022: 402023: 502024: 1852025: 653
2007high 653 (2025) · low 0 (2007)2025

MAUDE reports naming product code LRK, 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
20071—00
2008310901
2009388211
2010819507
201110134069
2012101420445
20139233072
201411219049
20156117028
201610157018
20177170032
201810200061
201913150056
2020580024
202110126049
202211154040
20235156050
202462540185
2025141071653
202610631—

More from Ortho Publications, Inc.

2 FDA decisions under this applicant name. See the company

  • K874416Dental Anti-Snoring DeviceOrtho Publications, Inc. · 1988

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https://510kreport.com/device/K895189 · printed Nov 5, 2026

Cite this page

510(k) Report. “K895189: Adjustable Soft Palate Lifter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K895189

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026