510(k) Report

510(k) · Cleared

Cleared

Immufuge Disp. Liner

K780281510(k) TraditionalCleared Mar 2, 19789-day reviewClass I21 CFR 864.9275

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

Dade, Baxter Travenol Diagnostics, Inc. · KSO Centrifuge, Blood-Bank For In Vitro Diagnostic Use

Cleared on Mar 2, 1978 after a 9-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 2, 1978
Review
9 days
Class
Class I
Product code
KSO
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K780281Source: 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 KSO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • 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 KSO devices

KSO Centrifuge, Blood-Bank For In Vitro Diagnostic Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KSO

FDA has decided no KSO device since 2007.

Median 510(k) review, days · KSO

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

Recalls per year · KSO

No recall names KSO since 2007.

Adverse event reports per year · KSO

2in 2009

2007: 32008: 52009: 2
2007high 5 (2008) · low 0 (2010)2025

MAUDE reports naming product code KSO, 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—03
20080—05
20090—02
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 Dade, Baxter Travenol Diagnostics, Inc.

44 FDA decisions under this applicant name. See the company

  • K800296Whole Blood Gas Control, Levels 1,2,&3Dade, Baxter Travenol Diagnostics, Inc. · 1980
  • K792606Whole Blood Platelet Control Normal,Dade, Baxter Travenol Diagnostics, Inc. · 1980
  • K792723Blood Fluid FiltersDade, Baxter Travenol Diagnostics, Inc. · 1980
  • K792607T3 Uptake (T3U) ReagentsDade, Baxter Travenol Diagnostics, Inc. · 1980
  • K792443TSH RadioimmunoassayDade, Baxter Travenol Diagnostics, Inc. · 1979

https://510kreport.com/device/K780281 · printed Nov 6, 2026

Cite this page

510(k) Report. “K780281: Immufuge Disp. Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K780281

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