510(k) Report

510(k) · Cleared

Cleared

Dialysate Meter RS-2100A, Circuit Change

K770263510(k) TraditionalCleared Feb 18, 19777-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

Renal Systems, Inc. · FLB Meter, Conductivity, Induction, Remote Type

Cleared on Feb 18, 1977 after a 7-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 18, 1977
Review
7 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 K770263Source: 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 Renal Systems, Inc.

35 FDA decisions under this applicant name. See the company

  • K970648Primus Hollow Fiber Dialyzer (Models 1000,1000S,1350,1350S,2000,2000S)Renal Systems, Inc. · 1998
  • K861730Actril for Kidney Machine DisinfectantRenal Systems, Inc. · 1987
  • K854011Renalfo Hemofilter CavhdRenal Systems, Inc. · 1985
  • K844790Renaflo HemoconcentratorRenal Systems, Inc. · 1985
  • K844108Renal Systems Peritoneal Access SystemRenal Systems, Inc. · 1985

Recent decisions in FLB

The FLB category page

  • K100237Dialysate Meter, Model D-6Myron L Company · 2010
  • K92521090DX Multitest Meter, ModificationMesa Medical, Inc. · 1994
  • K882032Model 90DX Multitest MeterMesa Medical, Inc. · 1988
  • K830629Cobe RX MeterCobe Laboratories, Inc. · 1983
  • K821415Model 90 BCWestern Laboratories Corp. · 1982

https://510kreport.com/device/K770263 · printed Nov 5, 2026

Cite this page

510(k) Report. “K770263: Dialysate Meter RS-2100A, Circuit Change.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K770263

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