510(k) Report

510(k) · Cleared

Cleared

90DX Multitest Meter, Modification

K925210510(k) TraditionalCleared Jan 25, 1994475-day reviewClass II21 CFR 876.5820

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

Mesa Medical, Inc. · FLB Meter, Conductivity, Induction, Remote Type

Cleared on Jan 25, 1994 after a 475-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 25, 1994
Review
475 days
Class
Class II
Product code
FLB
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K925210Source: FDA 510(k) database · 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 FLB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All FLB devices

FLB Meter, Conductivity, Induction, Remote Type: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FLB

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FLB

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

Recalls per year · FLB

No recall names FLB since 2007.

Adverse event reports per year · FLB

No MAUDE report names FLB since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20101—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 Mesa Medical, Inc.

7 FDA decisions under this applicant name. See the company

  • K882032Model 90DX Multitest MeterMesa Medical, Inc. · 1988
  • K870811Model 102 PH MeterMesa Medical, Inc. · 1987
  • K852749Recommended Alternative Dialyzer DisinfectantMesa Medical, Inc. · 1985
  • K843520Warexin Recommended Alternative DialyzMesa Medical, Inc. · 1984
  • K834447Echo MM1000Mesa Medical, Inc. · 1984

Recent decisions in FLB

The FLB category page

  • K100237Dialysate Meter, Model D-6Myron L Company · 2010
  • K882032Model 90DX Multitest MeterMesa Medical, Inc. · 1988
  • K830629Cobe RX MeterCobe Laboratories, Inc. · 1983
  • K821415Model 90 BCWestern Laboratories Corp. · 1982
  • K770263Dialysate Meter RS-2100A, Circuit ChangeRenal Systems, Inc. · 1977

https://510kreport.com/device/K925210 · printed Nov 5, 2026

Cite this page

510(k) Report. “K925210: 90DX Multitest Meter, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K925210

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