510(k) Report

510(k) · Cleared

Cleared

Mini OX Iii Oxygen Monitor

K833326510(k) TraditionalCleared Nov 3, 198337-day reviewClass I21 CFR 868.1030

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

Catalyst Research Corp. · BXL Algesimeter, Manual

Cleared on Nov 3, 1983 after a 37-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
Nov 3, 1983
Review
37 days
Class
Class I
Product code
BXL
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared1998: 1 descendant cleared1999: 1 descendant cleared19801990200020102020
  1. This deviceK833326 Mini OX Iii Oxygen MonitorCatalyst Research Corp. · 1983
  2. Descendant · cites it directly · 2 of its ownK961644 Miniox 3000 Oxygen MonitorMinesafety Appliances Co. · 1996
  3. Descendant · 2 generations on · 0 of its ownK991884 Siemens FIO2 SensorSiemens Medical Solutions USA, Inc. · 1999
  4. Descendant · cites it directly · 0 of its ownK971084 Model 02 Oxygen AnalyzerOxigraf, Inc. · 1998

Most influential descendants

Showing 3 of 3 · See all
  • K961644Miniox 3000 Oxygen MonitorMinesafety Appliances Co. · 1996 · cites it directly2descendants
  • K991884Siemens FIO2 SensorSiemens Medical Solutions USA, Inc. · 1999 · 2 generations on0descendants
  • K971084Model 02 Oxygen AnalyzerOxigraf, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K833326Mini OX Iii Oxygen MonitorCatalyst Research Corp.1983—
+1K961644Miniox 3000 Oxygen MonitorMinesafety Appliances Co.1996—
+2K991884Siemens FIO2 SensorSiemens Medical Solutions USA, Inc.1999—
+1K971084Model 02 Oxygen AnalyzerOxigraf, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
199910
FIG. 1 — Lineage of K833326, 1983–1999Source: 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 BXL? 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
K961644Miniox 3000 Oxygen MonitorMinesafety Appliances Co.19962
K971084Model 02 Oxygen AnalyzerOxigraf, Inc.19980

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, K961644 (Minesafety Appliances Co., 1996) has gone furthest, with 2 descendants of its own.

How does its category compare?

All BXL devices

BXL Algesimeter, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BXL

FDA has decided no BXL device since 2007.

Median 510(k) review, days · BXL

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

Recalls per year · BXL

No recall names BXL since 2007.

Adverse event reports per year · BXL

No MAUDE report names BXL since 2007.

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
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 Catalyst Research Corp.

9 FDA decisions under this applicant name. See the company

  • K905310Miniox V Pulse OximeterCatalyst Research Corp. · 1991
  • K874132Miniox IV Portable Pulse OximeterCatalyst Research Corp. · 1988
  • K862798Miniox 100 Pulse OximeterCatalyst Research Corp. · 1986
  • K833995Mini OX IICatalyst Research Corp. · 1983
  • K790784Model M25R, Oxygen AnalyzerCatalyst Research Corp. · 1979

https://510kreport.com/device/K833326 · printed Nov 6, 2026

Cite this page

510(k) Report. “K833326: Mini OX Iii Oxygen Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K833326

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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