510(k) Report

510(k) · Cleared

Cleared

Safety Stop Neckstrap

K780814510(k) TraditionalCleared Jun 30, 197843-day reviewClass I21 CFR 872.5525

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

Northwest Orthodontics, Inc. · DYT Maintainer, Space Preformed, Orthodontic

Cleared on Jun 30, 1978 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 30, 1978
Review
43 days
Class
Class I
Product code
DYT
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K780814Source: FDA 510(k) database · 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 DYT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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?

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.

How does its category compare?

All DYT devices

DYT Maintainer, Space Preformed, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DYT

FDA has decided no DYT device since 2007.

Median 510(k) review, days · DYT

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

Recalls per year · DYT

No recall names DYT since 2007.

Adverse event reports per year · DYT

9in 2025

2016: 12017: 42018: 52019: 82020: 22021: 12022: 82023: 142024: 132025: 9
2007high 14 (2023) · low 0 (2007)2025

MAUDE reports naming product code DYT, 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
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—04
20180—05
20190—08
20200—02
20210—01
20220—08
20230—014
20240—013
20250—09
20260—0—

More from Northwest Orthodontics, Inc.

6 FDA decisions under this applicant name. See the company

  • K800748Snap-Way HeadgearNorthwest Orthodontics, Inc. · 1980
  • K790843Snap-WayNorthwest Orthodontics, Inc. · 1979
  • K780747Snap-WayNorthwest Orthodontics, Inc. · 1978
  • K771706Saif-BowNorthwest Orthodontics, Inc. · 1977
  • K771095J Hook HeadgearNorthwest Orthodontics, Inc. · 1977

Recent decisions in DYT

The DYT category page

  • K935856Dentaurum Space MaintainerDentauraum, Inc. · 1994
  • K864376FiberbondDentec, Inc. · 1987
  • K812239Unitek Palatal BarUnitek Corp. · 1981

https://510kreport.com/device/K780814 · printed Nov 6, 2026

Cite this page

510(k) Report. “K780814: Safety Stop Neckstrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K780814

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