510(k) Report

510(k) · Cleared

Cleared

Lyfo (TM) Differential Disk

K945488510(k) TraditionalCleared May 11, 1995184-day reviewClass I21 CFR 866.2660

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

Microbiologics, Inc. · JSP Kit, Anaerobic Identification

Cleared on May 11, 1995 after a 184-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 11, 1995
Review
184 days
Class
Class I
Product code
JSP
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K945488Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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 JSP devices

JSP Kit, Anaerobic Identification: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JSP

FDA has decided no JSP device since 2007.

Median 510(k) review, days · JSP

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

Recalls per year · JSP

No recall names JSP since 2007.

Adverse event reports per year · JSP

2in 2021

2015: 142016: 132017: 232018: 102020: 12021: 2
2007high 23 (2017) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—014
20160—013
20170—023
20180—010
20190—00
20200—01
20210—02
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Microbiologics, Inc.

18 FDA decisions under this applicant name. See the company

  • K190086Cepheid Xpert Respiratory Control PanelMicrobiologics, Inc. · 2019
  • K191168Cepheid Xpert SA Nasal Complete Control PanelMicrobiologics, Inc. · 2019
  • K191172Cepheid Xpert MRSA NxG Control PanelMicrobiologics, Inc. · 2019
  • K190223Cepheid Xpert CT/NG Control PanelMicrobiologics, Inc. · 2019
  • K190463Cepheid Xpert C. difficile/Epi Control PanelMicrobiologics, Inc. · 20191 recall

Recent decisions in JSP

The JSP category page

  • K945487Lyfo (TM) Differential DiskMicrobiologics, Inc. · 1995
  • K945489Lyfo (TM) Differential DiskMicrobiologics, Inc. · 1995
  • K944528Bblcrystal Anaerobe ID SystemBecton Dickinson Microbiology Systems · 1995
  • K910666Vitek Anaerobe Identification Card, ModificationVitek Systems, Inc. · 1991
  • K900996Vitek Anaerobe Identification CardVitek Systems, Inc. · 1990

https://510kreport.com/device/K945488 · printed Nov 3, 2026

Cite this page

510(k) Report. “K945488: Lyfo (TM) Differential Disk.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K945488

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