510(k) Report

510(k) · Cleared

Cleared

S/P Vortex Mixer

K813148510(k) TraditionalCleared Nov 24, 198118-day reviewClass I21 CFR 862.2050

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

American Dade · JRQ Shaker/Stirrer

Cleared on Nov 24, 1981 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 24, 1981
Review
18 days
Class
Class I
Product code
JRQ
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K813148Source: 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.

Planning a device in JRQ? 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
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What was it cleared against?

FDA has not posted a summary or statement for it, 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 JRQ devices

JRQ Shaker/Stirrer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JRQ

FDA has decided no JRQ device since 2007.

Median 510(k) review, days · JRQ

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

Recalls per year · JRQ

No recall names JRQ since 2007.

Adverse event reports per year · JRQ

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code JRQ, 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—01
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 American Dade

149 FDA decisions under this applicant name. See the company

  • K873051Stratus (R) HFSH Fluorometric Enzyme ImmunoassayAmerican Dade · 1987
  • K873171Stratus (R) CK-MB Fluorometric Enzyme ImmunoassayAmerican Dade · 1987
  • K873052Stratus (R) HLH Fluorometric Enzyme ImmunoassayAmerican Dade · 1987
  • K872789Paramax Urine/CSF CalibratorAmerican Dade · 1987
  • K872195Data-FI Dimertest Latex AssayAmerican Dade · 1987

Recent decisions in JRQ

The JRQ category page

  • K813318Mini-ShakerDynatech Corp. · 1981
  • K813149S/P Vortex Mixer JR.American Dade · 1981
  • K801145Smi Multi-Tube VortexerScientific Manufacturing Industries · 1980
  • K790753Dimensionall RotatorAmerican Hospital Supply Corp. · 1979
  • K790027Shaker, Model SH-510Sysmex Corp. · 1979

https://510kreport.com/device/K813148 · printed Nov 6, 2026

Cite this page

510(k) Report. “K813148: S/P Vortex Mixer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K813148

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