510(k) Report

510(k) · Cleared

Cleared

Opticath

K820674510(k) TraditionalCleared Mar 25, 198214-day reviewClass II21 CFR 870.1230

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

Oximetrix, Inc. · DQE Catheter, Oximeter, Fiber-Optic

Cleared on Mar 25, 1982 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Mar 25, 1982
Review
14 days
Class
Class II
Product code
DQE
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 2 descendants cleared2014: 1 descendant cleared19801990200020102020
  1. This deviceK820674 OpticathOximetrix, Inc. · 1982
  2. Descendant · cites it directly · 1 of its ownK061585 Opticath Central Venous Oximetry CatheterHospira, Inc. · 2006 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK140129 Piccox Peripherally Inserted Pressure Injectable, Central Venous…Icu Medical, Inc. · 2014
  4. Descendant · cites it directly · 0 of its ownK061159 Opticath Central Venous Oximetry Probe with Fluidic Seal…Hospira, Inc. · 2006

Most influential descendants

Showing 3 of 3 · See all
  • K061585Opticath Central Venous Oximetry CatheterHospira, Inc. · 2006 · cites it directly1descendant
  • K140129Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry CatheterIcu Medical, Inc. · 2014 · 2 generations on0descendants
  • K061159Opticath Central Venous Oximetry Probe with Fluidic Seal with/Without HeparinHospira, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K820674OpticathOximetrix, Inc.1982—
+1K061585Opticath Central Venous Oximetry CatheterHospira, Inc.20061
+2K140129Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry…Icu Medical, Inc.2014—
+1K061159Opticath Central Venous Oximetry Probe with Fluidic Seal with/Without HeparinHospira, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
201410
FIG. 1 — Lineage of K820674, 1982–2014Source: FDA 510(k) summaries, read by 510(k) Report · 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 DQE? 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? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061585Opticath Central Venous Oximetry CatheterHospira, Inc.20061
K061159Opticath Central Venous Oximetry Probe with Fluidic Seal with/Without HeparinHospira, Inc.20060

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, K061585 (Hospira, Inc., 2006) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DQE devices

DQE Catheter, Oximeter, Fiber-Optic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQE

1in 2018

2009: 12011: 12014: 12016: 12018: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQE

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

Recalls per year · DQE

No recall names DQE since 2007.

Adverse event reports per year · DQE

31in 2025

2007: 202008: 122009: 512010: 642011: 542012: 792013: 582014: 382015: 582016: 682017: 472018: 382019: 632020: 392021: 392022: 572023: 482024: 472025: 31
2007high 79 (2012) · low 12 (2008)2025

MAUDE reports naming product code DQE, 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—020
20080—012
20091—051
20100—064
20111—054
20120—079
20130—058
20141—038
20150—058
20161—068
20170—047
20181—038
20190—063
20200—039
20210—039
20220—057
20230—048
20240—047
20250—031
20260—0—

More from Oximetrix, Inc.

12 FDA decisions under this applicant name. See the company

  • K853018Model 3000 Opticath ComputerOximetrix, Inc. · 19862 recalls
  • K842622Hemo Static/Esu Scalpel SystemOximetrix, Inc. · 1984
  • K833966Pump Infusion Wearable Infusion PumpOximetrix, Inc. · 1984
  • K823007Opticath Heparin Coated, Flow-DirectOximetrix, Inc. · 1982
  • K821056Flow Directed Thermal-Dilution CatheterOximetrix, Inc. · 1982

Recent decisions in DQE

The DQE category page

  • K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter…Edwards Lifescience, LLC · 20181 recall
  • K160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC · 2016
  • K140129Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry CatheterIcu Medical, Inc. · 2014
  • K110167Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin)Edwards Lifesciences, LLC · 2011
  • K091268Hospira Latex-Free Critical Care and Advanced Sensor CathetersHospira, Inc. · 20095 recalls

https://510kreport.com/device/K820674 · printed Nov 6, 2026

Cite this page

510(k) Report. “K820674: Opticath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K820674

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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