510(k) Report

510(k) · Cleared

Cleared

STC Diagnostics Auto-Lyte (R) Methaqualone Eia

K950308510(k) TraditionalCleared Apr 14, 199579-day reviewClass I21 CFR 874.3540

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

Solarcare Technologies Corp,Inc. · JXS Block, Cutting, Ent, Sterile

Cleared on Apr 14, 1995 after a 79-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Apr 14, 1995
Review
79 days
Class
Class I
Product code
JXS
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 K950308Source: 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 JXS devices

JXS Block, Cutting, Ent, Sterile: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JXS

FDA has decided no JXS device since 2007.

Median 510(k) review, days · JXS

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

Recalls per year · JXS

No recall names JXS since 2007.

Adverse event reports per year · JXS

No MAUDE report names JXS 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 Solarcare Technologies Corp,Inc.

28 FDA decisions under this applicant name. See the company

  • K954326STC Diagnostics Auto-Lyte Urinary Hemoglobin AssaySolarcare Technologies Corp,Inc. · 1996
  • K954156STC Diagnostics Auto-Lyte Urinary Leukocyte Esterase AssaySolarcare Technologies Corp,Inc. · 1996
  • K955905STC Diagnostics Auto-Lyte Urinary Protein AssaySolarcare Technologies Corp,Inc. · 1996
  • K954158STC Diagnostics Auto-Lyte PH AssaySolarcare Technologies Corp,Inc. · 1996
  • K940048STC Diagnostics PCP Micro-Plate Eia ModificationSolarcare Technologies Corp,Inc. · 1996

Recent decisions in JXS

The JXS category page

  • K822371Micro WorktableTreace Medical, Inc. · 1982

https://510kreport.com/device/K950308 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950308: STC Diagnostics Auto-Lyte (R) Methaqualone Eia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950308

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