Mucicarmine Stain, #HT30

K832953510(k) TraditionalCleared Sep 29, 198329-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 Sep 29, 1983 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided: Sep 29, 1983
Review: 29 days
Class: Class I
Product code: HZC
Recalls: None
Predicates: 0

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

FIG. 1 — Lineage of K832953Source: 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 HZC? 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 HZC devices

HZC Mucicarmine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HZC

FDA has decided no HZC device since 2007.

Median 510(k) review, days · HZC

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

Recalls per year · HZC

No recall names HZC since 2007.

Adverse event reports per year · HZC

No MAUDE report names HZC 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/K832953 · printed Nov 3, 2026

Cite this page

510(k) Report. “K832953: Mucicarmine Stain, #HT30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K832953

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Record history

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