Chang Medium (Additional Indications)

K883682510(k) TraditionalCleared Sep 16, 198818-day reviewClass I21 CFR 864.2220

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

Hana Biologics, Inc. · KIT Media And Components, Synthetic Cell And Tissue Culture

Cleared on Sep 16, 1988 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided: Sep 16, 1988
Review: 18 days
Class: Class I
Product code: KIT
Recalls: None
Predicates: 0

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

FIG. 1 — Lineage of K883682Source: 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 KIT devices

KIT Media And Components, Synthetic Cell And Tissue Culture: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KIT

FDA has decided no KIT device since 2007.

Median 510(k) review, days · KIT

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

Recalls per year · KIT

4in 2018

2007high 4 (2018) · low 0 (2007)2026

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

Adverse event reports per year · KIT

1in 2020

2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code KIT, not matched to any one device; reports are not rates.

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	—	0	1
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	4	0
2019	—	0	0
2020	—	0	1
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

https://510kreport.com/device/K883682 · printed Nov 4, 2026

Cite this page

510(k) Report. “K883682: Chang Medium (Additional Indications).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K883682

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Record history

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