510(k) Report

510(k) · Cleared

Cleared

Liquichek Blood Gas Plus CO-Oximeter Control, Models 637, 638, 639 (Radiometer)

K002536510(k) TraditionalCleared Aug 30, 200014-day reviewClass I21 CFR 862.1660

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

Bio-Rad · JJS Controls For Blood-Gases, (Assayed And Unassayed)

Cleared on Aug 30, 2000 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Aug 30, 2000
Review
14 days
Class
Class I
Product code
JJS
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared200020052010201520202025
  1. This deviceK002536 Liquichek Blood Gas Plus CO-Oximeter Control, Models 637, 638, 639…Bio-Rad · 2000
  2. Descendant · cites it directly · 0 of its ownK022525 Liquichek Blood Gas Plus CO-Oximeter Control (Radiometer 700 Series)…Bio-Rad · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K022525Liquichek Blood Gas Plus CO-Oximeter Control (Radiometer 700 Series) Levels, 1,2 and 3…Bio-Rad · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002536Liquichek Blood Gas Plus CO-Oximeter Control, Models 637, 638, 639 (Radiometer)Bio-Rad2000—
+1K022525Liquichek Blood Gas Plus CO-Oximeter Control (Radiometer 700 Series) Levels…Bio-Rad2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K002536, 2000–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 JJS? 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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022525Liquichek Blood Gas Plus CO-Oximeter Control (Radiometer 700 Series) Levels, 1,2 and 3…Bio-Rad20020

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.

What does this lineage say?

  • Of its descendants, K022525 (Bio-Rad, 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JJS devices

JJS Controls For Blood-Gases, (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJS

1in 2016

2013: 22015: 12016: 1
2007high 2 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJS

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

Recalls per year · JJS

No recall names JJS since 2007.

Adverse event reports per year · JJS

1in 2018

2017: 12018: 1
2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code JJS, 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—00
20132—00
20140—00
20151—00
20161—00
20170—01
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

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322 FDA decisions under this applicant name. See the company

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Recent decisions in JJS

The JJS category page

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https://510kreport.com/device/K002536 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002536: Liquichek Blood Gas Plus CO-Oximeter Control, Models 637, 638, 639 (Radiometer).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002536

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