510(k) · Cleared
ClearedKJ Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kj Meditech Co., Ltd. · DZB Headgear, Extraoral, Orthodontic
Cleared on Jun 9, 2011 as substantially equivalent to K923556 (Ormco Corp., 1992) after a 240-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Jun 9, 2011
- Review
- 240 days
- Class
- Class II
- Product code
- DZB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923556 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK923556 Adp FacemaskOrmco Corp. · 1992
- This deviceK103019 KJ MaskKj Meditech Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923556 | Adp Facemask | Ormco Corp. | 1992 | — |
| 0 (this device) | K103019 | KJ Mask | Kj Meditech Co., Ltd. | 2011 | — |
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 DZB? 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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K923556 | Adp FacemaskSummary page 1…l Orthodontic Headgear Classification regulation: 21CFR872.5500 Product Code: DZB 2. Predicate Device: ADP Face Mask by Ormco Corp. (K923556) 3. Description: KJ Mask (KM 102-S, KM 201 -L) is a device made of materials such as aluminum alloy, sta… | 1992 |
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?
- Its one ancestor has no recall.
How does its category compare?
All DZB devicesDZB Headgear, Extraoral, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DZB
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DZB
Too few DZB 510(k)s in any year since 2007 to give a median.
Recalls per year · DZB
No recall names DZB since 2007.
Adverse event reports per year · DZB
1in 2021
MAUDE reports naming product code DZB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
KJ Mask is used as a treatment option for Class III malocclusions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103019: KJ Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103019
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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