510(k) Report

510(k) · Cleared

Cleared

Therapeutic Exchange System

K831423510(k) TraditionalCleared Jan 3, 1984245-day reviewClass III

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

Extracorporeal Medical Specialities, Inc. · LQQ Columns, Immunoadsorption In Extracorporeal Systems

Cleared on Jan 3, 1984 after a 245-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 3, 1984
Review
245 days
Class
Class III
Product code
LQQ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K831423Source: 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 LQQ? 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
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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 LQQ devices

LQQ Columns, Immunoadsorption In Extracorporeal Systems: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LQQ

FDA has decided no LQQ device since 2007.

Median 510(k) review, days · LQQ

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

Recalls per year · LQQ

No recall names LQQ since 2007.

Adverse event reports per year · LQQ

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code LQQ, 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—01
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 Extracorporeal Medical Specialities…

69 FDA decisions under this applicant name. See the company

  • K843955Extracorporeal Maxima Hollow Fiber OxygenatorExtracorporeal Medical Specialities, Inc. · 1984
  • K840532Hemoperfusion System TP-400Extracorporeal Medical Specialities, Inc. · 1984
  • K840262Hancock Pericardial PatchExtracorporeal Medical Specialities, Inc. · 1984
  • K840057Exp* 500 Parallel Plate DialyzerExtracorporeal Medical Specialities, Inc. · 1984
  • K840146Exp* 700 Parallel Plate DialyzerExtracorporeal Medical Specialities, Inc. · 1984

https://510kreport.com/device/K831423 · printed Nov 4, 2026

Cite this page

510(k) Report. “K831423: Therapeutic Exchange System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K831423

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