Eosin Y Solutin, Agueous

K821574510(k) TraditionalCleared Jun 10, 198214-day reviewClass I21 CFR 864.1850

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

Cleared on Jun 10, 1982 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided: Jun 10, 1982
Review: 14 days
Class: Class I
Product code: HYB
Recalls: None
Predicates: 0

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

FIG. 1 — Lineage of K821574Source: 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.

Planning a device in HYB? 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 HYB devices

HYB Eosin Y: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HYB

FDA has decided no HYB device since 2007.

Median 510(k) review, days · HYB

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

Recalls per year · HYB

3in 2010

2007high 3 (2010) · low 0 (2007)2026

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

Adverse event reports per year · HYB

No MAUDE report names HYB since 2007.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	3	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

https://510kreport.com/device/K821574 · printed Nov 4, 2026

Cite this page

510(k) Report. “K821574: Eosin Y Solutin, Agueous.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K821574

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Record history

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