Orthodontic Nitinol Springs

K881331510(k) TraditionalCleared Apr 21, 198823-day reviewClass I21 CFR 872.3285

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

Cleared on Apr 21, 1988 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided: Apr 21, 1988
Review: 23 days
Class: Class I
Product code: EJW
Recalls: None
Predicates: 0

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

FIG. 1 — Lineage of K881331Source: FDA 510(k) database · How lineage is built

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.

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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 EJW devices

EJW Clasp, Wire: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EJW

FDA has decided no EJW device since 2007.

Median 510(k) review, days · EJW

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

Recalls per year · EJW

No recall names EJW since 2007.

Adverse event reports per year · EJW

No MAUDE report names EJW since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K881331 · printed Nov 6, 2026

Cite this page

510(k) Report. “K881331: Orthodontic Nitinol Springs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881331

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Record history

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