510(k) Report

510(k) · Cleared

Cleared

Stool Transport/Processor

K933370510(k) TraditionalCleared Feb 17, 1994223-day reviewClass I21 CFR 866.2900

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

Sage Products, Inc. · LKS Device, Parasite Concentration

Cleared on Feb 17, 1994 after a 223-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Feb 17, 1994
Review
223 days
Class
Class I
Product code
LKS
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 K933370Source: 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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  • Recall history across each candidate’s familyin the report
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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 LKS devices

LKS Device, Parasite Concentration: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LKS

FDA has decided no LKS device since 2007.

Median 510(k) review, days · LKS

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

Recalls per year · LKS

No recall names LKS since 2007.

Adverse event reports per year · LKS

No MAUDE report names LKS 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
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Sage Products, Inc.

31 FDA decisions under this applicant name. See the company

  • K972705Resheather Device-Metal or Plastic, Resheater/ Needle Holder Device-PlasticSage Products, Inc. · 1998
  • K980490Sage Products Inc, Sharps Disposal Containers with Screw Top CapsSage Products, Inc. · 1998
  • K9739112 Gallon Alternate Care Sharps ContainerSage Products, Inc. · 1997
  • K972279Sharps ShuttleSage Products, Inc. · 1997
  • K970135Nitrile GlovesSage Products, Inc. · 1997

Recent decisions in LKS

The LKS category page

  • K053257Para-Pro FC50Alpha-Tec Systems, Inc. · 2006
  • K021420Paracon II/Fecal Concentrator IIPara Scientific Co. · 2002
  • K980077Para-Pak SpinconMeridian Diagnostics, Inc. · 1998
  • K941110ParakitHardy Diagnostics · 1994
  • K941129Con-KitMedical Chemical Corp. · 1994

https://510kreport.com/device/K933370 · printed Nov 5, 2026

Cite this page

510(k) Report. “K933370: Stool Transport/Processor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K933370

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