510(k) Report

510(k) · Cleared

Cleared

Dimension Enzymatic Carbonate (ECO2) Flex Method, Catalog DF137

K010206510(k) TraditionalCleared Mar 16, 200152-day reviewClass II21 CFR 862.1160

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

Dade Behring, Inc. · KHS Enzymatic, Carbon-Dioxide

Cleared on Mar 16, 2001 after a 52-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Mar 16, 2001
Review
52 days
Class
Class II
Product code
KHS
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2014: 1 descendant cleared200020052010201520202025
  1. This deviceK010206 Dimension Enzymatic Carbonate (ECO2) Flex Method, Catalog DF137Dade Behring, Inc. · 2001
  2. Descendant · cites it directly · 1 of its ownK061238 Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase…Dade Behring, Inc. · 2006 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK133728 Dimension Vista Creatinine (CRE2) Flex Reagent CartridgeSiemens Healthcare Diagnostics, Inc. · 2014

Most influential descendants

Showing 2 of 2 · See all
  • K061238Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase Flex Reagent…Dade Behring, Inc. · 2006 · cites it directly1descendant
  • K133728Dimension Vista Creatinine (CRE2) Flex Reagent CartridgeSiemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010206Dimension Enzymatic Carbonate (ECO2) Flex Method, Catalog DF137Dade Behring, Inc.2001—
+1K061238Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase Flex…Dade Behring, Inc.20061
+2K133728Dimension Vista Creatinine (CRE2) Flex Reagent CartridgeSiemens Healthcare Diagnostics, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201410
FIG. 1 — Lineage of K010206, 2001–2014Source: 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 KHS? 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
Get a 510(k) Report

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? (2)

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

NumberDeviceApplicantDecidedDescendants
K061238Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase Flex Reagent…Dade Behring, Inc.20061

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, K061238 (Dade Behring, Inc., 2006) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KHS devices

KHS Enzymatic, Carbon-Dioxide: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KHS

1in 2017

2007: 22008: 12009: 12010: 32011: 12012: 22013: 22014: 12016: 12017: 1
2007high 3 (2010) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KHS

143in 2010

2010: 143 days median
2007high 143 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KHS

1in 2025

2013: 12019: 12023: 12025: 1
2007high 1 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KHS

40in 2025

2008: 22009: 142011: 52012: 32013: 22014: 62015: 12016: 42017: 72018: 152019: 352020: 312021: 142022: 102023: 252024: 302025: 40
2007high 40 (2025) · low 0 (2007)2025

MAUDE reports naming product code KHS, 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
20072—00
20081—02
20091—014
2010314300
20111—05
20122—03
20132—12
20141—06
20150—01
20161—04
20171—07
20180—015
20190—135
20200—031
20210—014
20220—010
20230—125
20240—030
20250—140
20260—0—

More from Dade Behring, Inc.

347 FDA decisions under this applicant name. See the company

  • K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
  • K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and…Dade Behring, Inc. · 2008
  • K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension…Dade Behring, Inc. · 2008
  • K071603Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008
  • K071597Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator…Dade Behring, Inc. · 2008

Recent decisions in KHS

The KHS category page

  • K170200Carbon Dioxide Reagent SetTeco Diagnostics, Inc. · 2017
  • K152085Liquid CO2-2 (LCO2-2)Randox Laboratories, Ltd. · 2016
  • K140248S Test Reagent Cartridge Carbon Dioxide (CO2)Hitachi Chemical Diagnostics, Inc. · 2014
  • K131546AU Bicarbonate ReagentBeckman Coulter Ireland, Inc. · 20134 recalls
  • K123953Ace Carbon Dioxide Reagent, Ace Direct Biliubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2013

https://510kreport.com/device/K010206 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010206: Dimension Enzymatic Carbonate (ECO2) Flex Method, Catalog DF137.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010206

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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