510(k) Report

510(k) · Cleared

Cleared

Hematic Blood Mixer

K802608510(k) TraditionalCleared Dec 11, 198051-day reviewClass I21 CFR 864.9195

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

Helmer Labs, Inc. · KSQ Device, Blood Mixing And Blood Weighing

Cleared on Dec 11, 1980 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 11, 1980
Review
51 days
Class
Class I
Product code
KSQ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K802608Source: 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 KSQ? 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 KSQ devices

KSQ Device, Blood Mixing And Blood Weighing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KSQ

FDA has decided no KSQ device since 2007.

Median 510(k) review, days · KSQ

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

Recalls per year · KSQ

No recall names KSQ since 2007.

Adverse event reports per year · KSQ

1in 2025

2012: 12025: 1
2007high 1 (2012) · low 0 (2007)2025

MAUDE reports naming product code KSQ, 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—00
20120—01
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—01
20260—0—

More from Helmer Labs, Inc.

3 FDA decisions under this applicant name. See the company

  • K812533Platelet AgitatorHelmer Labs, Inc. · 1981
  • K770830Platelet AgitatorHelmer Labs, Inc. · 1977

Recent decisions in KSQ

The KSQ category page

  • K842746Hycel Rotor-Mixer and/or MultiR&D Systems, Inc. · 1984
  • K820712Sepcor Unit Collection MonitorSeparation Science Corp. · 1982
  • K812533Platelet AgitatorHelmer Labs, Inc. · 1981
  • K810617Mobile Matic Automatic Donor ScaleLifeline Instruments, Inc. · 1981
  • K800104Royco Model 951 Cell MixerRoyco Instruments · 1980

https://510kreport.com/device/K802608 · printed Nov 6, 2026

Cite this page

510(k) Report. “K802608: Hematic Blood Mixer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K802608

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