510(k) · Cleared
ClearedFresh Cells WI-38
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Hybrids, Inc. · KIR Cells, Animal And Human, Cultured
Cleared on Sep 25, 1997 as substantially equivalent to K962306 (Diagnostic Hybrids, Inc., 1996) after a 29-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Sep 25, 1997
- Review
- 29 days
- Class
- Class I
- Product code
- KIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962306 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK962306 Fresh Cells Multi-Well & Shell Vial CulturesDiagnostic Hybrids, Inc. · 1996
- This deviceK973212 Fresh Cells WI-38Diagnostic Hybrids, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962306 | Fresh Cells Multi-Well & Shell Vial Cultures | Diagnostic Hybrids, Inc. | 1996 | — |
| 0 (this device) | K973212 | Fresh Cells WI-38 | Diagnostic Hybrids, Inc. | 1997 | — |
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.
Planning a device in KIR? 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
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 | Decided |
|---|---|---|---|
| * | K962306 | Fresh Cells Multi-Well & Shell Vial Cultures Our OCR of the scanned summary read “36271” beside “510(k)”; FDA’s K962306 is the only number that fits it and carries the summary’s name for the device. Summary page 1…evice provides HEL, HFF, LLC-MK;, MvlLu, NCI H292, Vero and WI- cells (in addition to MRC-5, McCOY, BGMK, and CV-1, under 510 (k) 36271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cells™) as nearly confluent monolayers ready for use… | 1996 |
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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All KIR devicesKIR 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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KIR
1in 2009
MAUDE reports naming product code KIR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 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/K973212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973212: Fresh Cells WI-38.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973212
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026