510(k) Report

510(k) · Cleared

Cleared

Prospect Cryptosporidium Rapid Assay

K936191510(k) TraditionalCleared Nov 17, 1994329-day reviewClass II21 CFR 866.3220

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

Alexon Biomedical, Inc. · MHJ Cryptosporidium Spp.

Cleared on Nov 17, 1994 after a 329-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Nov 17, 1994
Review
329 days
Class
Class II
Product code
MHJ
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 K936191Source: 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 MHJ devices

MHJ Cryptosporidium Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MHJ

1in 2017

2013: 12017: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHJ

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

Recalls per year · MHJ

No recall names MHJ since 2007.

Adverse event reports per year · MHJ

No MAUDE report names MHJ since 2007.

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
20131—00
20140—00
20150—00
20160—00
20171—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Alexon Biomedical, Inc.

5 FDA decisions under this applicant name. See the company

  • K964864Prospect II Clostridium Diffillie Toxin a Microplate AssayAlexon Biomedical, Inc. · 1997
  • K955157Prospect Giardia/Cryptosporidium Microplate AssayAlexon Biomedical, Inc. · 19962 recalls
  • K933997Prospect Entamoeba Histolytica Microplate AssayAlexon Biomedical, Inc. · 1993
  • K874849Prospect/GiardiaAlexon Biomedical, Inc. · 1988

Recent decisions in MHJ

The MHJ category page

  • K171078Tri-Combo Parasite ScreenTechlab, Inc. · 2017
  • K121565Uni-Gold CryptosporidiumTrinity Biotech · 2013
  • K051929Giardia/Cryptosporidium ChekTechlab, Inc. · 2005
  • K052932Cryptosporidium IITechlab, Inc. · 2005
  • K031965Xpect Cryptosporidium Lateral Flow Assay, Model 2451020Remel, Inc. · 20031 recall

https://510kreport.com/device/K936191 · printed Nov 5, 2026

Cite this page

510(k) Report. “K936191: Prospect Cryptosporidium Rapid Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K936191

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