510(k) Report

510(k) · Cleared

Recalled · 2008

MXR-2000 Flowmeter

K923781510(k) TraditionalCleared Jun 10, 1993317-day reviewClass I21 CFR 868.2340Recalls 1

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

Porter Instrument Co., Inc. · CAX Flowmeter, Tube, Thorpe, Back-Pressure Compensated

Cleared on Jun 10, 1993 after a 317-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Jun 10, 1993
Review
317 days
Class
Class I
Product code
CAX
Recalls
1
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared1990200020102020
  1. This deviceK923781 MXR-2000 FlowmeterPorter Instrument Co., Inc. · 1993
  2. Descendant · cites it directly · 0 of its ownK062155 Digital MXR-D FlowmeterPorter Instrument Co., Inc. · 2006 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K062155Digital MXR-D FlowmeterPorter Instrument Co., Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K923781MXR-2000 FlowmeterPorter Instrument Co., Inc.1993—
+1K062155Digital MXR-D FlowmeterPorter Instrument Co., Inc.20061

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K923781, 1993–2006Source: 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.

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  • 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
K062155Digital MXR-D FlowmeterPorter Instrument Co., Inc.20060

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 26, 2008Not classifiedZ-0228-2009Employee errorinverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K062155 (Porter Instrument Co., Inc., 2006) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CAX devices

CAX Flowmeter, Tube, Thorpe, Back-Pressure Compensated: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAX

FDA has decided no CAX device since 2007.

Median 510(k) review, days · CAX

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

Recalls per year · CAX

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · CAX

4in 2025

2007: 52008: 42009: 272010: 72011: 132012: 52013: 52014: 12015: 22017: 42018: 32019: 62020: 12021: 62022: 12023: 32024: 12025: 4
2007high 27 (2009) · low 0 (2016)2025

MAUDE reports naming product code CAX, 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—05
20080—14
20090—027
20100—07
20110—013
20120—05
20130—05
20140—01
20150—02
20160—00
20170—04
20180—03
20190—06
20200—01
20210—06
20220—01
20230—03
20240—01
20250—04
20260—0—
Cite this page

510(k) Report. “K923781: MXR-2000 Flowmeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923781

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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