Zenkers Solution

K842732510(k) TraditionalCleared Aug 3, 198421-day reviewClass I21 CFR 864.4010

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

Cleared on Aug 3, 1984 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided: Aug 3, 1984
Review: 21 days
Class: Class I
Product code: IFH
Recalls: None
Predicates: 0

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

FIG. 1 — Lineage of K842732Source: 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 IFH? 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 IFH devices

IFH Solution, Zenker'S: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IFH

FDA has decided no IFH device since 2007.

Median 510(k) review, days · IFH

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

Recalls per year · IFH

No recall names IFH since 2007.

Adverse event reports per year · IFH

No MAUDE report names IFH 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/K842732 · printed Nov 5, 2026

Cite this page

510(k) Report. “K842732: Zenkers Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K842732

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Record history

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