510(k) · Cleared

Cleared

Fresh Cells Vero

K973209510(k) TraditionalCleared Sep 25, 199729-day reviewClass I21 CFR 864.2280

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

Diagnostic Hybrids, Inc. · KIR Cells, Animal And Human, Cultured

Cleared on Sep 25, 1997 after a 29-day review. Our reading found no predicate number; beside “510(k)” the summary reads “K936271”, which our checks could not confirm as its predicate.

Decided: Sep 25, 1997
Review: 29 days
Class: Class I
Product code: KIR
Recalls: None
Predicates: 0

Our reading found no predicate number; beside “510(k)” the summary reads “K936271”, which our checks could not confirm as its predicate.

FIG. 1 — Lineage of K973209Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	—	BioWhittaker cell cultures Named without a submission number			—

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 KIR devices

KIR Cells, Animal And Human, Cultured: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KIR

FDA has decided no KIR device since 2007.

Median 510(k) review, days · KIR

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

Recalls per year · KIR

1in 2009

2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · KIR

1in 2009

2007high 1 (2009) · low 0 (2007)2025

MAUDE reports naming product code KIR, 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	—	1	1
2010	—	0	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	—

What is it indicated for?

FreshCells™ are indicated for use in the isolation of various viruses and Chlamydia from clinical specimens. Viruses and Chlamydia are intracellular parasites which can be cultured or grown only in specific cellular hosts. They cause a variety of diseases in man with some virus infections being lethal, particularly if the individual is immunocompromised. With the introduction of several new and specific antiviral drugs over the last several years, the need to determine the identity of the viral agent has become even more important. Culture of viruses in specific cell lines has become the standard for the identification of these viruses.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973209 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973209: Fresh Cells Vero.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973209

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026